Clinical Project Manager Resume Samples

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J Toy

Johnpaul

Toy

582 Letha Junctions

Philadelphia

+1 (555) 842 9163

582 Letha Junctions

Philadelphia

Phone

p +1 (555) 842 9163

Experience Experience

San Francisco, CA

Clinical Project Manager

San Francisco, CA

Prohaska, Moen and Hermiston

San Francisco, CA

Clinical Project Manager

Provide performance feedback of team members to respective line managers and engage line management in problem resolution
Provides project management and lean methodology services and education, defines scope and establishes milestones
Assist Clinical Affairs Manager/Director for building departmental process improvement initiatives
Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines
Identify resistance and performance gaps, and work to develop and implement corrective actions
May have line management responsibilities for the recruitment, training, utilization, development and performance review of assigned staff

Phoenix, AZ

Associate Clinical Project Manager

Phoenix, AZ

Upton-Jakubowski

Phoenix, AZ

Associate Clinical Project Manager

Assist in the development and management of study budgets
Provide input to the development of integrated study management plans with the core project team and/or sub-team
Coordinate data gathering for the development of proposals for new work
Shows commitment to and performs consistently high quality work
Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
Assist the clinical project manager(s) with budget allocation and approval of invoices
Prepares and manages RFP’s for vendors with oversight from manager

present

Los Angeles, CA

Senior Clinical Project Manager

Los Angeles, CA

Pouros and Sons

present

Los Angeles, CA

Senior Clinical Project Manager

present

Provide input for the development of proposals for new work and manage project budgets
Provide input to line managers of their project team members’ performance relative to project tasks
Provide input for the development of proposals for new work and project budgets
Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff
Assist eCRF development
Report on team performance against contract, customer expectations, and project baselines to management
Provide other project support to Managers, as assigned

Education Education

Bachelor’s Degree in Life Sciences

University of Florida

Bachelor’s Degree in Life Sciences

Skills Skills

Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
Excellent ability to interact with physicians and other professionals inside and outside the company
Strong knowledge of applicable computer and project management software packages
Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
Strong communication and presentation skills, including good command of English language
Excellent customer service skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients
Strong leadership with excellent organizational and problem solving skills
Strong organizational skills and the ability to prioritize multiple tasks and projects
Extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
Strong communication, presentation and interpersonal skills with high attention to detail and organization

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15 Clinical Project Manager resume templates

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Clinical Project Manager Resume Examples & Samples

5+ years of relevant experience
Strong understanding of clinical studies including ICH-GCP guidelines and applicable regulatory requirements
Master's Degree in related field
CCRA certification
Experience with Oncology

Clinical Project Manager Resume Examples & Samples

BS/BA, Masters' degree preferred in Life Science
Candidates should have 5-7 years relevant work experience
Experience with Oncology is preferred
Possess highly effective interpersonal skills enabling them to lead a team through negotiation, coaching and mentoring, have a strong understanding of clinical studies including ICH-GCP guidelines and applicable regulatory requirements, and display flexibility and integrity
Well organized and detail oriented, have strong written and verbal communication skills, be proficient in MS Office Suite, and have the ability to give presentations, multi-task and work effectively in a team or independently on assigned tasks

Clinical Project Manager Resume Examples & Samples

Direct reporting to the Accounting Manager and working in a team environment
Handle financial reporting and analysis
Perform USGAAP adjustment and monthly consolidation
Participate in ad hoc financial projects

Senior Clinical Project Manager Resume Examples & Samples

Represents and leads the study team to design, develop and deliver the clinical study to agreed upon timelines
Authors/contributes to clinical study documents
Reviews and approves study related plans generated by Clinical CROs and vendors
Provides input as the subject matter expert for the study during regulatory inspections
Executes the clinical study in accordance with the project clinical development strategy and timelines
Responsible for the clinical review and/or approval of Case Report Forms (electronic as applicable), and provides clinical input into corresponding completion guidelines
Responsible for oversight of identification and selection of investigator sites
Responsible for planning and conducting investigator’s meetings
Collaborates with the cross functional team on selection and management of clinical vendors
Manages escalation of study related isses and communicates as appropriate with management and other R&D functions
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
Trains and manages CRO and other clinical vendor activities to ensure the quality meets Shire and regulatory requirements
Monitors the status of clinical data collection of assigned clinical studies
Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required
Reviews correspondence and monitoring reports relating to the study
Evaluates CRO and vendor performance for future work
Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested
Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable)
May mentor other Study Managers
Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or similar organization
Strong knowledge of applicable computer and project management software packages
Familiarity with financial budgeting and forecasting or reporting
Ability to interact with invesigators, vendors, and individuals at all levels of the organization
Working knowledge of current global regulatory requirements and guidelines governing clinical research

Clinical Project Manager Resume Examples & Samples

Manages or assists in the planning, implementation, and execution of a clinical research study(ies)
Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc
May author, review and approve various study related documents and plans
Leads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study
Leads and/or assists the study team to design, develop and deliver the clinical study to agreed upon timelines
May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors
40%
Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines
Contributes to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines
Leads/assists in oversight of the identification and selection of investigator sites
Assists and/or participates in planning and conduct of investigator’s meetings
Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team
Collaborates with the cross functional team on selection and potentially management of clinical vendors
Liaises and coordinates with document specialists regarding study files
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions
May support or co-manage larger complex trials as necessary
Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements
May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
Reviews clinical monitoring reports and correspondence related to monitoring visits
Responsible for maintaining tracking information in the clinical trial management system and confirming resolution of data quality issues with the CRO
Ensures effective communication between Shire and the Clinical CRO
Reviews and approves study plans
Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans
May provide periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested
May develop and/or monitor budget for clinical study (investigational sites and vendors)
May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors
Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities
Supports departmental initiatives and process improvements
Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required
Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization
Familiarity with project management software or tools
Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines
Ability to work successfully within a cross-functional team and a matrix organization
Ability to interact with invesigators, vendors, and internal colleages
Knowledge of current regulatory requirements and guidelines governing clinical research

Clinical Project Manager Resume Examples & Samples

Bachelor’s degree in related discipline required
10+ years of clinical research study management experience
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development
Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross-functional drug development

Clinical Project Manager / cra Resume Examples & Samples

Bachelor's Degree Nursing Degree preferred
5+ years of pharmaceutical or clinical experience
Prior experience in clinical operations, leading, mentoring and training CRAs within CRO environment
Manage and prioritize timelines and budget of assigned studies
Ability to identify, analyze problems and trends; provide and recommend solutions, in the context of sound business assessment and decision making
A demonstrated sense of urgency, the ability and under tight deadlines is a must and have strong problem solving skills
Thorough knowledge of ICH, GCP, SOPs
80-90 percent travel
Nursing Degree
1+ years of direct report management desirable

Clinical Project Manager Resume Examples & Samples

Bachelor's Degree or related work experience
5+ years of pharmaceutical or clinical experience required
1+ years of clinical monitoring experience or equivalent
Knowledge of FDA regulations and their practical implementation
Proficiency with computers, particularly MS Office
1+ years of direct report management
Phase 1-4 experience
MS or equivalent work experience
GCP, ICH, and SOP
25 percent travel

Clinical Project Manager Resume Examples & Samples

Works with an energetic and dynamic multidisciplinary skin cancer team to provide individual and support services to patients and their families
Serves as the primary point person for high-risk and complex skin cancer patients to coordinate care between Mohs surgery, USC Tina and Rick Caruso Department of Otolaryngology-Head and Neck Surgery, plastic surgery, surgical oncology, medical oncology, and radiation oncology, among others
Assists with designing and implementing cutting edge oncology and surgical research protocols
Participates building other aspects of the USC procedural dermatology program including but not limited to minimally invasive vein procedures, medical and aesthetic lasers, and other cosmetic procedures
Provides health promotion, counseling and education on skin cancer prevention
Great opportunities for learning, growth, and advancement in an academic, teaching environment on Keck Health Science Campus
Desirable outpatient clinic day-shift work schedule

Clinical Project Manager Resume Examples & Samples

Minimum of 2 years of related experience in a clinical supplies or pharmaceutical environment
Excellent attendance and work record
Strong proficiency in MS Office and Adobe InDesign

Cerner Clinical Project Manager Resume Examples & Samples

Develops standards, templates, and procedures to aid in the development of the required work products (Methodology)
Reviews programs designed from high level specifications or derived logical processes (DLPs) ensuring that they meet client specifications (Technical)
Establishes and maintains networking relationships with middle management in client organizations (Relationship Management)
Understands client needs and matches them to relevant services or products; manages client expectations (Leverage)
Understands and communicates goals and critical success factors for the project; sells ideas persuasively and paces the communications properly (Communication)
Five or more years of experience in business analysis and design, preferably within a consulting environment
Experience working with techniques and approaches for process and entity modeling

Cerner Clinical Project Manager Resume Examples & Samples

Project Execution: Ensure delivery of the respective Epic Clinical and AEMR Applications in accordance with the vision, strategy, guiding principles, and business case
Resource Management: Lead Application Analyst with project management activities; create application-specific project plan; provide coaching and direction to specified application team so that they successfully meet their responsibilities
Project Management: Responsible for day-to-day administration of the Cerner implementation project, with assistance from the Process Lead and application team members; manage the project workplan to ensure on-time completion of deliverables and achievement of milestones; monitor project status taking action to prevent timeline slippage; meet project budget; make project performance transparent through formal status reporting and measurement of progress against metrics
Project Deliverables: Develop project deliverables and facilitate review and approval process with Process Lead, Program Director and, as required, project governance
Issues Resolution/Risk Mitigation: Adhere to issues resolution and risk mitigation processes; ensure that issues are resolved or escalated to appropriate forums for resolution; identify barriers to project success and support risk mitigation planning
Vendor Management: Manage relationship with Epic implementation team, and respective consultants and contractors; conduct ongoing review of the respective project with the Epic Implementation Coordinator; Represent application related issues and needs to Cerner’s Implementation team
Team Leadership: Conduct weekly team meetings to discuss team and project related activities, issues, change, communications, and updates. The team leadership will be a joint leadership responsibility that combines the Application Project Manager, a Process Team Lead, and a LEAN Process Specialist to lead each project team
Manages project teams of 10-15 resources (company, client and third-party resources) across all phases of the project life cycle (Management)
Oversees assigned personnel for project. Assigns work and provides direction with regard to timeliness and completion of project objectives. Addresses performance issues within prescribed guidelines. Provides performance input upon completion of project. (Management)
Customizes methodology to meet specific project and client needs (Methodology)
Influences decisions and project direction at the executive level (Relationship Management)
Participates in proposal efforts and sales calls (Leverage)
Bachelor's degree or equivalent combination of education and experience, with Bachelor's degree in related field preferred
Five or more years working with Cerner Millennium including either implementation or support of the system
Five or more years of Project Management experience
Five or more years of consulting experience managing medium to large-sized projects of medium to high complexity
Two to five years of additional relevant experience in one or more technical, business or industry specialty areas

Self Medication Clinical Project Manager M/w Resume Examples & Samples

Strong understanding of cosmetic development process, significant experience in the management of multiple development projects,
Extensive experience in clinical trial planning and oversight, interacting with clinical investigators and Contract Research Organizations,
Experience working cross-functionally and building collaborative working relationships,
Entrepreneurial spirit with a “can do” attitude, a commitment to teamwork and an initiative taker,
Autonomy in decision making and knowledge of the working environment

Clinical Project Manager Resume Examples & Samples

Contribute to the study protocol (ie ensure operational aspects are realistic and feasible) and budget development, interacting proactively with the other functions especially Project Managers from Business and Clinical Operations
Assess & pronounce on clinical sites & staff's suitability to conduct the protocol. Secure stakeholders agreement with the assessment outcome
Lead and co-ordinate all activities to operationalize the study protocol, in an independent fashion, leading to the delivery of clinical trial statistical report according to the agreed Clinical Development Unit baseline timeline
Conduct all operational activities according to internal SOPs & ICH GCP guidelines to ensure and document quality of collected data
Track & manage study contracts to provide timely and accurate input into financial management systems and so delivering study to agreed budget. Reporting on budget to concerned SBU or business Project Manager
Prepare, review & quality control essential study documents and collate all in Trial Master File. TMF documents collectively demonstrate adherence to ICH GCP guidelines and applicable laws. Required in case of inspection by national regulatory bodies or audit by IRB/EC or others
Minimum of 4-5 years clinical project management experience in Food/Pharma/CRO industry
Educational background in biological science or other relevant science
Experience of working with clinical sites to execute protocols
Experience in leading & coordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders
Fluency in spoken and written English, other languages is a plus

Clinical Project Manager Resume Examples & Samples

Contribute to the study and/or site budget development, protocol outline development (i.e. ensure operational aspects are realistic and feasible) Case Report Form development and Informed Consent Form template development. Submits to IRBs and Ethics Review Committees as required
Oversee the site feasibility and qualification process for identification of qualified investigational sites per protocol requirements. Assess and pronounce on clinical site(s) and personnel suitability to conduct the protocol
Serve as the liaison and/or Subject Matter Expert when defining the scope for vendor and/or site contracts. Facilitate obtaining the required legal, ethical and technical agreements with sites and vendors as needed
Lead and co-ordinate all activities to operationalize the study protocol inclusive of CRO and other vendor oversight, in an independent fashion, leading to the delivery of clinical trial statistical report according to the agreed baseline timeline
Manage overall activities to ensure compliance with internal SOPs, FDA regulations & ICH GCP guidelines. Adherence to vendor SOPs if defined in vendor contracts
Track & manage study contracts per their defined scope and budget. Provide timely and accurate financial status to financial management system and stakeholders as required
Prepare, review & quality control essential study documents and collate all in Trial Master File or confirm that CRO provides adequate TMF documentation. TMF documents collectively demonstrate adherence to ICH GCP guidelines and applicable laws. Required in case of inspection by national regulatory bodies or audit by IRB/EC or others
Contribute to continuous improvement of working processes to optimize efficiencies
Ensure trial subject protection
Management & coaching of CRAs and other clinical trial personnel
Experience of managing multi-site, international clinical studies
Experience of risk assessment, implementation of mitigation plans and continuous review and adjust to plans as required
Clinical experience, for example, any health care professional qualification

Clinical Project Manager Resume Examples & Samples

Design, direct, manage and implement all aspects of the daily operations of the project related to the training, editing and successful implementation of the online training system, SOARING 2
Manage training schedules, trainers and materials/equipment with the Contracting Officer; and oversee modification to online and face-to-face training curricula to suit agency needs and requests
Oversee the development of certified coaches in SOARING 2 skills throughout the agency; coordinate review and critique of coach/trainee interview tapes; and prepare written reports on progress of training, coaching, taped interviews, and quality of officer interactions with clients/offenders
Monitor status of server space used to house the recordings of taped interactions
Prepare administrative accounting and financial reports to ensure all assigned products are delivered on-time and within budget
Create a collaborative relationship with the federal agency’s Contracting Officer and other project staff, and serve as the primary liaison with the contractor headquarters
Ensure collection of all data required for ongoing project evaluation; and
Provide guidance to other contractor personnel involved in the project; and ensure that all project issues, including content changes as determined by the government, are successfully resolved
Master’s degree in a related field
Able to organize and track multiple people and projects simultaneously
Able to flexibly manage changes to project scope, schedule, costs and resources as necessary
Proficiency in financial tracking and recording budget expenses
Fluent in evidence-based practices in community corrections; familiarity with SOARING 2
Knowledgeable about adult learning theory and implementation science
Extensive demonstrated experience (minimum of 15 years is strongly desired) training in topics such as risk/need assessment, interventions to support behavior change/incentives and sanctions, motivational interviewing, case planning, criminal thinking, etc., with substantial knowledge of the operations of community corrections
Has experience with coding and critiquing of audio- or video-taped interviews for assessment of specific skill proficiency and overall quality of interaction between practitioner and client
Possess excellent written and oral communication; and strong proficiency with Microsoft Office and Web-based conferencing software
Able to provide online and classroom training, along with professional coaching, with superior people skills; and
Experience in curriculum development and agency-wide implementation of innovative practices, with adjustment to site-specific requirements

Clinical Project Manager Resume Examples & Samples

Attends Project Meetings at the business or customer site. Leads and represents the business at kick off meetings as required by the customer
Provides accurate and timely financial forecasting and reporting
Responsible for revenue recognition for projects and verifies final information for Accounting Department prior to invoices release
Participates in cross-functional business process improvement activities as required
Requires strong and effective communication with the ability to effectively present information and respond to questions from groups of managers and clients
Requires knowledge of all internal systems associated with projects (i.e. Salesforce, Master Control Trackwise, IN-TRAK II)
As a Global Project Lead (GPL), the following additional qualifications
Requires 3 years of successful experience in clinical trial project management as a Project Manager or Coordinator
Requires in depth understanding of clinical trials
Requires proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook)
Requires proven experience with customers in a dynamic environment
Requires excellent communication, organizational skills and project coordination skills
Prefer proficiency in appropriate project planning tools (e.g. Microsoft Project) to communicate milestones and critical path activities and responsibilities
Mastery of basic Project Management concepts as a recognized institution in project management

Senior Clinical Project Manager Resume Examples & Samples

Coordinate and complete annual implementation and expansion projects across clinical functional areas within the defined constraints of scope, quality, schedule, budget, resources and risks
Support white glove project communication, foster excellent stakeholder engagement, and prepare and present project and progress updates that exceed the expectations of senior leadership
Review and synthesize evidence, including anecdotal feedback, to identify and mitigate project and performance risks
Prioritize work load to support ad hoc projects as assigned
BA / BS degree and/or equivalent education and experience
4+ years of experience in tracking, planning projects, working with large data sets and making data - driven analytical decisions
Clinical License - RN
Demonstrated familiarity with PMBOK, Six Sigma, LEAN and other project management methodologies
Demonstrated ability to communicate ideas and project constraints clearly and concisely
Managed care experience
Experience in a Project Management Office (PMO)

Ubc-senior Clinical Project Manager Resume Examples & Samples

Supervise project management staff in execution of assigned studies
Prepare PMs to make presentations to clients in defense of proposals
Ensure that the PM understands the client needs once a project is awarded
Serve as a resource and mentor to the Project Manager in the execution of their daily activities
Proactively assist the PM in anticipating and seeking resolutions to potential and actual project issues

Clinical Project Manager Resume Examples & Samples

Collaborate with Beacon Health Leadership team to initiate work plans and utilize best practices and process improvement to meet the business objectives of Beacon Health
Help drive process changes for the purpose of operational efficiencies
Ensure project/work-plan timelines and deliverables are met
Assist in leading complex clinical and sensitive business/departmental projects to ensure successful outcome and delivery of benefits, within time, cost and quality
Gain acceptance and understanding of current processes/new business change
Communicate any identified resistance and performance gaps to leaders and assist in developing corrective action plans
Identify communication needs with internal and external stakeholders at all levels, and build relationships with them throughout the life cycle of the project. Manage complex, difficult or potentially contentious issues, successfully influencing and managing stakeholder expectations, including reconciling conflicting views with regards to a project's direction
Maintain effective relationships with relevant parties
Ability to work with multi-disciplinary groups internally and externally
Maintain individual level of Project Management knowledge through periodic education and training specific to industry standard Project Management tools and methodologies
Prepares project status reports and keeps administration, clients, and others informed of project status and related issues
Develops and maintains historical documentation of previous project issues, resolutions, risks, accomplishments, resource consumption and task completion variances for purposes of planning/estimating future projects
Consults with Beacon Health leadership team and reviews project proposals to determine goals, timeframe, funding limitations, and procedures for accomplishing project work, staffing requirements and allotment of resources
Identify potential people-side risks and anticipated points of resistance, and develop specific plans to mitigate or address the concerns
Create and enable reinforcement mechanisms and celebrations of success
Bachelor's degree required and 5 years of related clinical experience or the equivalent combination of education and experience is required. Master's degree in business or healthcare administration preferred
Must have knowledge of Database software; Project Management software; Workflow management software; Spreadsheet software and Word Processing software
Must have at least three years experience in project management in a health care system and has led multiple clinical projects
Medical Terminology a plus
Evidence of building relationships with and managing expectations of stakeholders at all levels and externally, to persuade on business benefits and gain acceptance to changes. Understands the clinical and business operations of inpatient services, ambulatory, and physician practices
Strong interpersonal skills with capability to design and lead meetings, interviews and workshops with a range of audiences across the organization and externally
Strong communication skills, with ability to translate complex, difficult or potentially contentious issues into clear options, appraisals and reports, tailored to the audience
Sound analytical and problem solving techniques with ability to prioritize problems and demonstrate resourcefulness in their resolution
Strong clinical knowledge and experience necessary to manage projects appropriately
Excellent active listening skills
Must be a team player and able to work with and through others
Ability to influence others and move toward a common vision or goal
Must be able to displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
Project Management qualified

Clinical Project Manager Resume Examples & Samples

Leads, manages, plans, and executes small to intermediate sized projects
Manages change management efforts
Manages project recovery efforts
Provides project management and lean methodology services, defines scope and establishes milestones
Coordinates efforts with other project managers and project teams support
Executes large project tasks as required
Updates and reports project status to customers
Coaches and trains the application of clinical processes used to improve health outcomes for the people supported
Facilitates work sessions with project teams and steering committees
Analyzes, develops, and implements clinical process changes
Actively participates in management and support of projects under the supervision of intermediate or senior project managers
Coaches project coordinators
Associate's degree in nursing or in a related clinical field and
Project Management Professional (PMP or CAPM)® certification from the Project Management Institute or actively working on certification within 18 months
LEAN certification within eighteen (18) months of employment or
Six Sigma Black Belt certification or certification within eighteen (18) months of employment
2-4 years Project Coordinator Experience or
0-2 years Project Management experience or
On a development plan to build formal project management skills and
One (1) year working in clinical environments
Project Management Professional (PMP or CAPM)® certification
LEAN Certification or
Six Sigma Black Belt certification
Ability to work under pressure with precision and accuracy
Demonstrated ability to organize and work with limited guidance
Moderate organizational, analytical, planning, and facilitation skills
Proficient with MS Office applications (MSWord, Excel, PowerPoint, Visio)
Experience mapping work flows or
Working knowledge of clinical work flow mapping
Working knowledge of EMR Applications

Clinical Project Manager Resume Examples & Samples

Leads, manages, plans, and executes projects of moderate scope, size, and complexity
Manages moderate sized projects from initiation through implementation and transition to operations
Must have knowledge of clinical and nursing care principles, procedures, and practices
Coaches associate project managers and project coordinators
Leads project recovery efforts
Leads change management efforts
Provides project management and lean methodology services and education, defines scope and establishes milestones
Coordinates efforts with other project managers; Directs efforts of activities within scope
Updates and reports project status to customers and sponsors
Develops and implements project management and lean educational materials and programs
Mentors, coaches and trains the application of clinical processes used to improve health outcomes for the people supported
Bachelor's degree in nursing or in a related clinical field and
3-6 years project management experience either leading full or specific project tracks
Two (2) years working in clinical environments
The position requires knowledge of: (1) procedures/measures for the securing of personal data, (2) information gathering techniques, procedures, and practices; (3) project planning and management procedures, practices, and techniques
Demonstrated ability to organize and work independently
Detail-oriented with the ability to work with multiple project sites
Strong organizational, analytical, planning, and facilitation skills
Good clinical work flow mapping work skills

Clinical Project Manager Resume Examples & Samples

Possession of a Master’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or six (6) years of related experience in lieu of degree
A minimum of ten (10) years of progressively responsible relevant experience in clinical research, including a minimum of six (6) years directly managing multiple concurrent clinical projects
Ability to communicate effectively, both verbally and in writing, with demonstrated expertise in grammar, syntax and format
Strong problem solving, planning, organizing, writing/editing and data collection skills
Ability to collectively organize others to work within a team setting in the production of high quality deliverables compliant with established guidelines, practices, and procedures
Must be detailed oriented with the ability to prioritize multiple tasks and projects
Ability to work in a clinical research setting both independently and within a team
Previous project management and/or study coordination experience
Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
Knowledge of clinical trial fieldwork concepts and practices
IRB and Data and Safety Monitoring Board (DSMB) knowledge
Policy experience
Infectious disease research experience

Clinical Project Manager Resume Examples & Samples

Possession of a Bachelor's degree in biomedical science or related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or four (4) years related experience in lieu of degree
A minimum of eight (8) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
Strong organizational skills and the ability to prioritize multiple tasks and projects
Exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and keep track of meeting minutes
Project management and/or study coordination experience including data management and research subcontracting
Extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
Supervisory experience
Professional certification in project management or subcontracting
Certified Institutional Review Board (IRB) or Clinical Research Professional
Familiarity with Federal Acquisition Regulations (FARs)

Clinical Project Manager Resume Examples & Samples

Possession of a Master’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or six (6) years related experience in lieu of degree
A minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing multiple concurrent clinical projects
Experience working in an international setting
Extensive training and experience in project management
Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
Exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations and participate in high level meetings as a program liaison
Clinical project management and/or study coordination experience including data management and research subcontracting
Extensive knowledge of Food and Drug Administration (FDA) regulations and GCPs
Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
Ability to work diplomatically with regulatory agencies within complex international environments
Experience in deployment and implementation processes
Ability to travel internationally up to 20%
Prior contracting experience
Familiarity with Federal Acquisition Regulations (FAR)

Senior Clinical Project Manager Resume Examples & Samples

Agree with Sponsor team and Line Functions on realistic project and trial timelines. Lead the Clinical Trial Team and assigned resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
Accountable for the writing of clinical protocols and related documents in collaboration with the Product Lifecycle Services or Sponsor Medical representative as appropriate
Accountable for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
In collaboration with the PLS or Sponsor Medical representative, lead the clinical trial or non-interventional study data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab.)
Accountable for project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrollment
Work with Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with PLS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance
Accountable for the development, management and tracking of trial budget working closely with the PLS Finance and Sponsor representative
Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote)
Good leadership, negotiation and project management skills
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process for pre-approved and post-launch products
Strong customer oriented mindset

Clinical Project Manager Resume Examples & Samples

This role is critical to the successful delivery of this key outcomes study considered of high importance by both Novartis Ireland and Novartis Global
Act as combined CPM and CTM for this study
Provide a central point for communication between CPO and RE/Global RWE team
Responsible for the management of study to timelines, budget and for the delivery of defined metrics
Responsibility for study site communication and engagement
Set-up and execute a study logistics plan
Key role in ensuring protocol adherence and data quality including site initiations, protocol training and data quality monitoring
Ethics and Regulatory compliance
Data management process selection and vendor oversight if applicable
Hold and coordinate investigator meetings as per identified need
Contract management with all parties including CROI/HBT and participating GP surgeries
Develop recruitment strategies and contingencies in conjunction with CROI and HBT
Develop and maintain relationships with investigators
Assume ambassadorial role to facilitate communication between sites and Novartis CPO and investigators
Author study monitoring reports and review of study monitoring reports
Ensure interim and end of study data cleaning activities are completed by study sites within set timeline
Responsible for the final Clinical Study Report
Significant experience in clinical research is required
Prior experience in a project management role
Previous experience in Cardiology an advantage, but not required (any TA background considered)
Proven track record in clinical operations including study set-up, protocol management, regulatory/ethics applications, and study logistics
Effective site management and organisational skills demonstrated ability to meet key study milestones

Clinical Project Manager Resume Examples & Samples

Ability to strategically and effectively communicate with cross-functional colleagues, internal leadership, and external professionals to appropriately convey essential information and ensure favorable project outcomes
Effectively and strategically advocate project needs and requirements to internal and external stakeholders
Familiarity with clinical biostatistics techniques and methods
Effective strategic, analytical and problem solving skills
Knowledge of computerized databases for the maintenance of scientific data
Basic understanding of statistics and statistical methods
Coordinate and lead multiple projects simultaneously in a fast-paced, highly matrixed work environment with minimal supervision
Able to build constructive and effective relationships; use diplomacy and tact
Train others and evaluate work from the perspective of the organization

Senior Clinical Project Manager Resume Examples & Samples

Essential Duties and Responsibilities include the following. Other duties may be assigned
Responsible for overall project planning and execution for multiple clinical protocols
Provides leadership in regularly scheduled study team meetings with both internal and external resources
Provides leadership to study team in the development of clinical protocols, amendments, informed consents, CRF/ source document design, protocol specific training documentation, administrative letters, IND safety reports and other written clinical documents
Establishes and maintains productive working relationships with vendors, clinical investigators, and clinical site study staff to ensure quality of deliverables
Manages Contract Research Organizations (CROs), vendors and contractors to ensure project requirements are met
Oversees data collection and responds to questions received from clinical site study staff regarding the protocol and any other study related issues
Ensures that protocol/project training (on-site and Investigator Meeting) for Investigators, Study Coordinators, Monitors and other key study personnel is conducted and appropriately documented as per Acorda SOP’s
Provides and tracks important safety information to required parties i.e.Acorda’s Director of Safety, Chief Medical Officer, Data Safety Monitoring Board and safety vendor, if applicable
Collaborates with Contract/Outsourcing function on vendor Request for Proposals (RFP), bid review and vendor contracting
Responsible for the development and negotiation of study budgets for clinical trial centers
Collaborates with Metrics/Timelines support function in the development of overall project timelines, management and tracking
Responsible for the overall management of site monitoring and associated documentation from study initiation through close-out to ensure compliance with regulatory requirements and Good Clinical Practice
Provides guidance to study team ensuring adequate management of the project Trial Master File
Visits sites quarterly to monitor compliance with the protocol. Provides mentoring, and ensures adequate training and monitoring is in place
Participates in the review and development of Acorda Clinical Standard Operating Procedures
Undertakes ongoing performance review, feedback and development of staff
Assists with talent recruitment and leads a highly motivated, efficient and effective team
Responsible for training and mentoring Assistant Clinical Project Managers
A Bachelor’s degree in a scientific or health-related field is required
Master’s degree in a scientific or health-related field is preferred
Minimum of seven to nine years of general clinical research experience, including on-site monitoring experience
Must have a minimum of five to seven years of experience in the management of clinical trials as a project manager at a pharmaceutical/biotech company or CRO
Prior supervisory experience is required
Advanced understanding of GCPs, FDA regulations and ICH guidelines is required
This position supervises the Assistant Clinical Project Manager(s.)
Provides guidance to subordinates based on organizational goals and company policies
Responsible for functional management of CRO’s and clinical staff assigned to the project
Therapeutic experience and knowledge in neurological and cardiovascular preferred, but not required
Must be proficient in MS Office Suite
Must demonstrate a keen attention to detail and timelines
Excellent writing, communication, and presentation skills
Demonstrated leadership and project management skills
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment
Demonstrated ability to stay abreast of trends and new information in the profession

Senior Clinical Project Manager Resume Examples & Samples

Visits sites quarterly to monitor compliance with the protocol
Provides mentoring, and ensures adequate training and monitoring is in place
Responsible for functional management of all vendor services for the project

Senior Clinical Project Manager Resume Examples & Samples

Ensure the execution of clinical study activities, from study start-up through close-out, are conducted with upmost quality and in accordance with study timeline and objectives
Provide management with routine updates regarding the status of ongoing studies
Ensure the consistency of operational activities across studies and indications
Review the clinical study protocol and supporting documents– Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, etc. to ensure seamless integration between clinical objectives and study performanc
In collaboration with the study team, develop and implement subject recruitment strategies, and ensure enrollment remains on track
Manage the vendor evaluation, selection, and contract process for outsourced activities
Develop and implement vendor oversight plans for outsourced activities; ensure documentation of oversight is appropriate
In collaboration with the Clinical Research Organization (CRO), ensure clinical monitoring resourcing needs and issue resolution are adequate for the study
Review vendor-generated documents for accuracy, quality and consistency
Develop and maintain relationships with internal and external stakeholders, including investigators and vendors
Collaborate with consultants and contractors on clinical study activities
Contribute to the development and implementation of standard operating procedures (SOPs) and common work practices
Complete other study and/or clinical operations activities, as needed
Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 5-7 years of experience in clinical research operations
Experience in one or more clinical studies (Phase 2 and/or 3) in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology
Understands and ensures adherence to SOPs, good clinical practice (GCP), and FDA regulations with strong understanding of inspection readiness
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA
Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs
Demonstrated project management expertise, including the leadership and development of cross functional teams
Demonstrated ability to work independently with exceptional organization and attention to detail

Clinical Project Manager Resume Examples & Samples

Communicating job expectations
Approving direct reports time sheets, requests for time off and/or overtime
Performing timely performance evaluations of direct reports
Coordinating and conducting new hire interviews; facilitating hiring decision
Training new hires on departmental processes and responsibilities
Working with upper management in the continued development, coordination and implementation of support functions, processes, training program and evaluation of same
Exploring new opportunities to add value to organization and departmental processes
Helping others to accomplish results
Performing other duties as assigned and deemed necessary
1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role
Working knowledge of GCH, ICH guidelines and FDA regulations

Assistant Clinical Project Manager Resume Examples & Samples

Establishing clear and measurable project operating guidelines including timelines, milestones and budget allowances
Performing project analysis and management
Providing team leadership including team training, communication and delegation
Ensuring deliverables are met
Keeping client and/or management advised of current issues, study progress
Responding to client inquires in a timely and professional manner
Strong interpersonal and communication skills, both verbal and written
1 + years experience working with clinical trials and/or within pharmaceutical environment required

Lead Clinical Project Manager Resume Examples & Samples

Directly manage, coach, mentor and allocate new projects for 5 – 7 CPM staff on the West Coast
Support staff internally as well as externally addressing client requests and concerns as necessary
Collaborate with Business Development Directors in the development and presentation of company capabilities calls/meetings
Lead initiatives to improve processes and increase efficiencies
Stay ahead of the curve in learning and understanding the latest company developments and tools available to the project teams to utilize in their studies
Develop client specific strategies that provide for the highest level of customer satisfaction and delivery of services
Support large programs and work closely with relationship management team on key accounts
Manage team’s assignments, delegating appropriate and challenging assignments to encourage growth, development and independence
Work with executive management and directors when prioritization of deliverables is required for multiple projects
Evaluate and monitor study progress and workload of project management staff to ensure projects are on time and within budget; affecting change when necessary
Provide updates and metrics to senior management
Perform functions of project manager when necessary
Ability to maintain professional and positive attitude
Previous management or project experience in clinical development of investigational medications required
5-7 years internal project management experience
5-7 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role
Medical Imaging experience a plus
Experience working with computer software including Word, Excel, Access and Project preferred

Clinical Project Manager Resume Examples & Samples

Participate in design and implementation of clinical protocols, data collection systems and final reports
Oversee the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations
Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements
Manage clinical and regulatory files; interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors
Monitor adherence to protocols and determines study completion
Bachelor's degree or higher in Life Sciences, Pharmacy, or Project Management
A life science/clinical background preferred
5+ years’ experience of pharmaceutical experience and have prior involvement with multi-center, multinational Phase 3 trials
Excellent and current knowledge of GCP, ICH and FDA regulations is expected
Experience in diabetes/metabolism is desirable
Previous NDA filing experience also desirable
Strong interpersonal, written and oral communications skills
Ability to function efficiently and independently in a fast-paced, changing environment
Prioritize and recognize most important aspects of development process
Self-motivated and willing to accept temporary responsibilities outside of initial job description

Clinical Project Manager, Early Phase Resume Examples & Samples

3 to 5 years related work experience in project management or related fields
Experience as Functional Team Leader in clinical/data management/logistics functions or proven experience in coordinating clinical trials
Presentation, speaking skills (business development experience desirable)
Knowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry regulations
Solid computer and internet skills including knowledge of MS-Office products such as Excel, Word, PowerPoint, and Project

Senior Clinical Project Manager Resume Examples & Samples

Able to develop and execute complex study plans in one or more clinical studies with minimal supervision
Provides oversight and integration activities of all Clinical Operations staff supporting assigned projects
Able to draft plans for multiple related studies, with oversight
Develops study budget(s) with oversight
Accountable for managing performance of direct reports through consistent dialog and in accordance with the Vertex performance management cycle
Responsible for ensuring employees adequately and in accord with Vertex management expectations oversee outsourced services to designated vendor partners
Responsible for ensuring completion of the appropriate performance management activities; covering primary roles and responsibilities, goal setting in alignment with Clinical Development Execution and corporate goals, promoting Vertex values, competencies, and individual career development plans
Ensures that employee relations are managed proactively and regularly to maximize the motivation and well-being of employees
Ensures that employees are trained, developed, and coached so that their capabilities comply with company and regulatory requirements, maximizing their contribution to the projects and/or clinical trials and developing their skills and competencies in their respective roles
Proactively manages project and resource issues that require attention on behalf of the department and liaises in consultation with the CDE Leadership to address and resolve resource issues
Drives the implementation of process improvements and initiatives with the objective of enhancing GC compliance, efficiency, and productivity of staff
Contributes to employee forums and incorporates feedback from individuals and the team to enhance knowledge sharing
Shares insights and lessons learned across CDE and exCDE functions to ensure alignment
Ensures internal compliance with Clinical Development SOP’s, guidelines and corporate compliance policies related to the clinical trial conduct aspects of GCP’s and other applicable regulations
Attends scientific meetings and builds relationships with Investigators, business partners
Participates in study data review and interpretation
Participates in and contributes to publication strategy and content
Assumes a lead role in the identification process of Investigators or vendors and assures proper prequalification of clinical sites
Ensures external and internal documentation prepared within the Clinical Operations function is completed in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials
M.S. (or equivalent experience) and 6+ years of relevant work experience
B.S. (or equivalent experience) and 8+ years of relevant work experience
Demonstrated Line/People Management Experience
Displays highly developed leadership qualities
Deep understanding of Clinical Operations and Drug Development. Expert on assigned protocols
Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents
Proactively seeks out and recommends process improvements
Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
Communicates clearly and effectively with internal and external key stakeholders
May contribute to Clinical Development Plans with some oversight
Consistently demonstrates overall leadership in Clinical Operations

Clinical Project Manager Resume Examples & Samples

Responsible for developing and managing approved trial budget(s)
Develops and oversees study operational plan(s)
Assists with protocol design and strategy and medical issue resolution
Proactively identifies project risks and resolves with some supervision
Participates in the selection of Investigators and vendors
May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
Strong study management track record showing clear proficiency in clinical project management skills
Solid vendor management skills
Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
Hands on Clinical Project Management

Clinical Project Manager Resume Examples & Samples

Manage and direct the efforts of CRAs assigned to project which includes managing performance, scheduling and work assignments
Define and communicate job descriptions, core competencies, performance standards and expectations
Monitor expenditure of funds relative to budgetary targets for assigned trials on an ongoing basis. Ensure that variances are identified and communicated to the appropriate personnel in a timely manner
Independently manage/handle assigned clinical study in-house or via CRO
Prepare the study budget in consultation with project management/line manager/business development for the assigned projects
Prepare the project/monitoring plan for the study/ies. Track and ensure that project timelines and milestones are being met. Maintain and update all trackers to evaluate the progress of the study
Implement the initiation of the study sites, with the appropriate follow up (co-monitoring, reviewing of reports, recruitment tracking) and close out (archiving of files, collecting of IP and trial materials) of study centers on the assigned projects
Doctorate, Masters or Bachelor’s degree. Major course of study must be science or health related, eg. MPharm, BPharm, MBBS, M.Tech (BioTech) MSc, Nursing qualification, etc
Previous experience working in site monitoring in phase I to III clinical trials either in CRO or a bio-pharmaceutical company. The candidate should have extensive experience running trials in respiratory indications such as COPD, Asthma, and Allergic Rhinitis
Minimum of 6 years of Clinical trial management experience, of which 3 years should be in managerial role
Thorough understanding of clinical research process and ICH GCP

Clinical Project Manager Resume Examples & Samples

Coordinate all clinical trial activities within Shire while managing the interfaces with Legal, Quality, Manufacturing (Clinical Science, Medical Affairs, Regulatory, GPV, MORE DM, Biostat, Clinical Scientific Affairs)
Have an oversight of all internal and external team activities as outlined in the RACI and guidance document between Shire and Quintiles or in contracts with other CROs
Support preparation for Regulatory inspections if needed
Understand and manage the study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with Quintiles. A clear understanding of the study objectives is mandatory to ensure appropriate and accurate study performance and oversight
Guide the performance of Clinical Project Coordinators and Clinical Research Associates working on assigned studies if applicable
Oversight of study product inventory for a specific protocol
Minimum 2 years of experience as a Clinical Project Manager or similar role
Excellent verbal and written communication skills required. Interpersonal and organizational skills are a must
Working knowledge of common office and scientific computer programs as Microsoft Word, Excel and Microsoft Project

Clinical Project Manager Resume Examples & Samples

Oversee clinical trial activities within Shire while managing the interfaces with Legal, Quality, Manufacturing (Clinical Science, Medical Affairs, Regulatory, GPV, MORE DM, Biostat, Clinical Scientific Affairs etc.)
Have an oversight of all internal and external team activities as outlined in the partnership documents/RACI and guidance document between Shire and the partner or in contracts with other CROs
Review/consult/approve study documents as required and outlined in the RACI for successful study oversight
Drive and support a collaborative culture with the partner/ CRO
BA/BS/Nursing degree or European equivalent education. Experience can be substituted for education if at least 5 years of CRA experience and 2 years of experience in project management or supervisory experience in the pharmaceutical, biotechnology industry, or medical device industry

Clinical Project Manager Resume Examples & Samples

Work with Trial Lead and trial Coordinator for the development, management and tracking of trial budget (internal and external costs) working closely with the GBS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Support the Trial Lead in the preparation and presentation of the trial budget to Sponsor representatives. Ensure cost reconciliation after trial completion in appropriate payment systems,
Work with Drug Supply Management to ensure appropriate planning and of trial medication as well as keep overview of drug availability
In collaboration with trial Lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages (as needed)
8 years’ Clinical Operations experience with at least 4 years managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization
Proven ability to work independently in a complex matrix environment (including remote)
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills
Willingness to act accountably in project / trial management

Senior Clinical Project Manager Resume Examples & Samples

Report on team performance against contract, customer expectations, and project baselines to management
Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk
Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties
Provide input for the development of proposals for new work and project budgets
Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs
Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff
Good team leadership skills

Clinical Project Manager Resume Examples & Samples

Managing and coordinating cross-functional project teams
Leading problem solving and resolution efforts to include management of risk, contingencies and issue resolution
Developing study management plans, together with team assignments and accountabilities and oversight of database maintenance

Clinical Project Manager Resume Examples & Samples

Collect information on team performance against contract, customer expectations, and project baselines
Lead problem solving and resolution efforts to include management of risk, contingencies and issues
Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team
Strong communication and interpersonal skills, including good command of English language

Senior Clinical Project Manager Resume Examples & Samples

Good judgment
Effective presentation skills
Ability to manage competing priorities

Clinical Project Manager Resume Examples & Samples

Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Participates in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex, local studies. Understand project strategy and translate the agreed upon approach
Develops integrated study management plans with the core project team and/or sub-team
Accountable for the execution of clinical studies, or assigned portion of clinical studies, per Contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
Monitor progress against Contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally
Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts
Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans
Serve as primary project contact with Customer
Build the cross-functional project team and/or sub-team(s) and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles
Responsible for ensuring the financial success of the overall project and/or project sub-team
Forecast and identify opportunities to accelerate activities to bring revenue forward
Identify changes in scope and manage change control process as necessary
Identify lessons learned and implement best practices
Adopt corporate initiatives and changes and serve as a change advocate when necessary
In depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Broad protocol knowledge; therapeutic knowledge desired
Good understanding of the competitive environment and how to communicate/demonstrate value through Quintiles solutions
Good understanding of, and experience managing, contractual obligations and implications
Strong understanding of project financials
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving

Clinical Project Manager Hemophilia Resume Examples & Samples

Has working knowledge and familiarity with US Federal Food and Drug Administration, ICH/GCP, APAC Drug Regulations and European Regulatory Authority requirements as applicable to a study
Excellent English verbal and written communication skills required
Ability to multitask with sharp attention to detail
Possess working knowledge of research objectives, protocol design and data collection standards
Working knowledge of common office and scientific computer programs as Microsoft Word, Excel and Project
Demonstrate leadership skills in order to direct clinical team in study preparation and execution and to effectively communicate in GDTs
Advanced scientific degree or equivalent experience (MS/MSc/PhD/MD preferred)
Several years of clinical research experience in the pharmaceutical or biotechnology industry with global clinical project management experience
Strong knowledge base of ICH-GCP, FDA, EMA, and PMDA regulations

Clinical Project Manager Immunology Resume Examples & Samples

Represent sponsor oversight and strategic guidance for national/regional/global clinical projects/studies performed by the strategic CRO or any other partner and other CROs under Shire’s sponsorship
Scheduling and budgeting for clinical trial execution
Ensuring clinical trials are conducted in accordance with Shire’s operating model, ICH GCP Guidelines, the Declaration of Helsinki and national regulations
Act as the Clinical Operations lead in cross-functional teams
Working knowledge and familiarity with US Federal Food and Drug Administration, ICH/GCP, and EMA requirements as applicable to a study
Ability to perform appropriate study oversight, Project Management skills are a must
Excellent verbal and written communication skills required as well as interpersonal and organizational skills
Must demonstrate leadership skills in order to direct clinical team in study preparation and execution
Preparation and working with MS Project Gantt Charts

Clinical Project Manager Late Phase Studies Resume Examples & Samples

Effectively manage vendors and budgets
Manage all operational aspects of the registries from start-up to close-out activities to assure adherence to timelines and achievement of goals while ensuring compliance with FDA, EMA, ICH/GCP, GPP and other applicable guidelines/regulations
Oversee global and local activities, such as
Scientific/health care field is required
Background with demonstrated success in clinical project management in the pharmaceutical industry or with CROs
Experience with observational/non-interventional studies preferred
Strong organizational, IT and communication skills
Experience in coordinating/overseeing vendors
Ability to communicate effectively and confidently with customers and colleagues at management levels throughout the organization
Highly motivated to manage projects independently
Ability to motivate, stimulate, and communicate across cross-functional groups
Ability to deal with an evolving and change-oriented environment, highly flexible
Ability to assess and solve problems in an efficient manner

Clinical Project Manager Hematology Resume Examples & Samples

Oversee clinical trial activities within Shire while managing the interfaces with Legal, Quality, Manufacturing (Clinical Science, Medical Affairs, Regulatory, GPV, MORE DM, Biostat, Clinical Scientific Affairs)
Have an oversight of all internal and external team activities as outlined in the partenership documents/RACI and guidance document between Shire and the partner or in contracts with other CROs
Guide and oversee study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with Quintiles. A clear understanding of the study objectives is mandatory to ensure appropriate and accurate study performance and oversight
Maintain current sites/trial status reports for management review
Review/consult/approve study documents as required and outlined in the RACI for a successful study oversight
Be main contact for Quintiles (or other CRO) for a specific program/study. This includes driving the project successfully and be a key stakeholder for clinical within the R&D organization
Communicate/escalate all relevant and critical issues to management in a timely manner
Drive and support a collaborative culture with the CRO partner
BA/BS/Nursing degree or European equivalent education. Experience can be substituted for education if at least 5 years of CRA experience and 2 years experience in project management or supervisory experience in the pharmaceutical, biotechnology industry, or medical device industry
Excellent verbal and written communication skills required. Interpersonal and organizational skills
Ability to perform appropriate study oversight. Project Management skills are a must
Working knowledge of research objectives, protocol design and data collection standards
Ability to travel 10 -20 % of time

Clinical Project Manager Resume Examples & Samples

Possession of a Master's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or six (6) years related experience in lieu of degree
A minimum of twelve (12) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing multiple concurrent clinical projects
Must be detail-oriented, creative and flexible
Ability to work in an international clinical research setting both independently and within a team
Previous project management and/or study coordination experience including data management, information technology (IT) and research subcontracting
Experience related to clinical operations (e.g., development of Standard Operating Procedures (SOPs), staff development and training, resourcing/staffing, and budget planning and execution)
Demonstrated success in previous positions in deployment and implementation processes
Understands data management systems and electronic data capture methods
Clinical Research or Project Management Professional with infectious disease experience

Clinical Project Manager CD Resume Examples & Samples

Willingness and capability to work effectively in a smaller pharma company
Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize
International clinical experience is highly preferred
Understanding of country specific, FDA, ICH, and GCP- equivalent requirements, principles, concepts, industry practices, and standards
Solid knowledge of drug development and clinical trial operations
Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs
Ability to build strong relationships with external parties, such as key opinion leaders and clinical investigators
Ability to work effectively as a team player in a complex, changing environment, intensely committed to success and getting the job done well
Position may require occasional evening and/or weekend commitment
Position may require 25-50% domestic and/or international travel

Clinical Project Manager Resume Examples & Samples

3-5 years experience in healthcare research or other science related field
3-5 years experience in project management
3-5 years experience in a clinical trial environment

Clinical Project Manager Resume Examples & Samples

Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree
A minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
Previous project management and/or study coordination experience including data management and research subcontracting

Clinical Project Manager Resume Examples & Samples

Manage multiple clinical projects across various Research Centers and at CIRI
Work closely with Research Center and CIRI staff to define the initiation and execution timelines for clinical research projects
Effectively collaborate with cross-functional project team including Research Managers, Investigators, Coordinators, Contract Analysts, Budget Analysts, and other administrative personnel
Actively communicates with, manages, and effectively influences external, non-CIRI individuals involved in clinical research initiation such as Sponsor personnel and private-practice research personnel
Proactively manage and resolve potential issues that would cause an impediment to the project’s progress
Consistently demonstrate the ability to multitask and delegate to achieve desired end results for all associated stakeholders
Ensures consistent and timely communication to all stakeholders on clinical project status
Evaluate the performance of clinical projects against the stated timeline and enrollment targets
Enforces project management standard practices
Assembles reports on project status, including progress and resource deployment
Identifies, monitors, and tracks risk
Monitors resource utilization
Travels as required
Ensures the quality and success of the project deliverables and is accountable for managing risks and issues that come up
Focuses on delivering projects on time and within planned scope
Minimum 3 years experience in clinical research including relevant experience as a team leader in clinical functions or proven experience in coordinating clinical trials
1-2 years of project management experience preferred
Experience leading project teams is required
Effective time management in order to meet daily metrics or team objectives
Excellent interpersonal, oral and written communication skills
Good consulting skills
Ability to travel as required
In-depth understanding and experience in the clinical trial process
Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
Compassion: Feeling with others, being one with others in their sorrows and joys, rooted in the sense of solidarity as members of the human community
Excellence: Outstanding achievement, merit, virtue; continually surpassing standards to achieve/maintain quality
Maintains confidentiality and protects sensitive data at all times

Clinical Project Manager Resume Examples & Samples

Works closely with clinical study scientists, other clinical study team members and investigators to develop a clinical study protocol which can be executed successfully
Coordinates study activities including: study design input, protocol design and preparation, investigator selection, coordinate and present investigator meetings or site initiations
Provides training to sites on the study protocol, study conduct, CRF completion and data management expectations
Assists in CRF design and vendors qualification (e.g., CROs, labs, suppliers, etc)
Serves as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedural questions and changes
Demonstrates knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs, including source data verification for integrity and consistency; includes monitoring and/or co-monitoring with CRO monitors or others who have been delegated the responsibility to manage study sites
Manage cost, timeline, and resource estimates throughout the life of the study
Maintains close relationships with principal investigators and CROs
Ensures that sites are conducting studies according to protocols / GCP/ Applicable regulatory guidelines and takes corrective actions where appropriate
Ensures that critical documents for studies are maintained at the sites
Manages other monitors during on-site monitoring activities. Accountable for clinical study products
Conduct site visits to CROs, active involvement in contract negotiations and in assessing the appropriate regulatory agency interactions with the chosen CROs
Lead expert on GCPs and SOPs
MBA Pharmaceutical Management or Post Graduate Diploma in Clinical Research
Minimum of 5 years of clinically-related experience of which 3 years must be in clinical project management for nutritional, investigational drug or device trials
Possess excellent interpersonal skills where he/she is required to interact with people across all levels, and with diverse backgrounds
Organizational skills such as; prioritization, multi-tasking and good follow-up, are essential and critical to the success of this role

Clinical Project Manager Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or four (4) years related experience in lieu of degree
A minimum of six (6) years progressively responsible experience in clinical research
Ability to demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level
In depth working knowledge of drug development or clinical trial fieldwork concepts and practices with specific knowledge of development and monitoring requirements
Ability to manage drug development and research projects, both independently and within a team
Ability to critique and evaluate scientific reports relative to drug development or clinical trials
Knowledge of federal regulations governing drug development and/or clinical research, including International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) requirements
Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks/projects
Ability to communicate effectively, orally and in writing, with non-technical and technical staff including senior level management and officials
Ability to effectively manage staff and render decisions and policy interpretations
Effective negotiation skills and ability to manage budgets and procurement
Knowledge of the principals of budgeting, contracting, engineering, legal, clinical and/or laboratory procedures, space management, laboratory renovations, and technical writing
Logistical experience

Senior Clinical Project Manager B Resume Examples & Samples

Develops clear and measurable project management plans; Defines timelines, milestones, and limitations to project staff and study sites
Establishes project metrics and project schedules with client representatives. Provides at least monthly project updates
Facilitate case report form development, review, approval, and finalization with the Data Management Team
Development of Manual of Procedures and site study binder including all required Sponsor Forms/Templates
Support clinical development of protocol/consent form documents
Facilitate local regulatory review committee approvals as required for multisite trials
Review/process protocol exceptions/deviations
Develop and provide study and/or protocol amendment training to sites
Participate in SOP development

Senior Clinical Project Manager Resume Examples & Samples

5-10 years of relevant clinical research experience
CNS experience a plus
University degree, preferably in a biologic/scientific discipline
Excellent oral and written communication skills, strong leadership skills, self-motivated, team-player, adaptable to a dynamic environment
Demonstrated ability to work in cross-functional teams and individuals
Develops approach to solutions and seeks guidance as appropriate
Works under a minimal level of oversight

Clinical Project Manager Resume Examples & Samples

Actively participate in the planning and supporting of clinical relationships with Key Opinion Leaders (KOLs) and speakers
Follow all EHS rules and procedures for the position. Report any EHS incidents and/or unsafe acts and conditions to supervision
Responsible for implementing and maintaining the effectiveness of the Quality System
Experience with regulations and standards affecting the medical diagnostic industry
Experience with or exposure to Good Clinical Practices
Ability to form and develop interpersonal, professional relationships; displays socially and professionally appropriate behavior
Demonstrated initiative and problem-solving skills
Familiarity with desktop computer office software

Clinical Project Manager Resume Examples & Samples

Possession of a Bachelor's degree in biomedical science from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or four (4) years related experience in lieu of degree
A minimum of ten (10) years related experience in a pharmaceutical, biotechnology and/or clinical environment including three (3) years directly managing multiple concurrent clinical projects
Ability to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and track meeting minutes
Previous project management and/or study coordination experience, including data management and research subcontracting
Extensive knowledge of Food and Drug Administration (FDA) regulations GCPs
Knowledge of clinical trial fieldwork concepts and practices with a specific focus on international clinical research guidelines related to site management requirements
Clinical Research or Project Management Professional (PMP) with infectious disease experience

Associate Clinical Project Manager Resume Examples & Samples

3-5 years of relevant clinical research experience
GI, CNS, oncology, or dermatology experience a plus
University degree, in a scientific discipline
Advanced degree is a plus
Thorough understanding of country level regulations, ICH and GCP guidelines
Excellent oral and written communication skills, self-motivated, team-player, adaptable to a dynamic environment
Ability to adapt to changing needs of the program
Highly productive team member, capable of making insightful contributions and influencing decision making

Associate Clinical Project Manager Resume Examples & Samples

Drives all aspects of small projects or sub-projects from initiation, planning, execution, control and closure. Manages all aspects proactively
Creates or assists in creation of project budgets and assists to manage project costs to budgets. Assists in development of enrollment projections, and drug supply needs as part of the budget
Responsible for creating and maintaining MS Project timelines for each assigned project
Assists with creation of Project Plans (e.g. Responsibility Table, and Communication Plans) for each project
May review and approve the site contract template and budget template and variations to the template
Becomes proficient at reviewing study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process)
Compiles study metrics for performance and quality for management
Becomes proficient at negotiation and management of competing priorities across multiple functional areas
Prepares and manages RFP’s for vendors with oversight from manager
Prepares high-quality reports (financial, project, etc.) for CPM on program status and issues
BA/BS or equivalent is preferred with a minimum of 4 years of pharmaceutical or biotech research experience
Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred
Ability to solve problems proactively
Proficiency with Excel and MS Project

Clinical Project Manager Resume Examples & Samples

Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the UCB internal and CRO teams
Articulate study scope, goals and expectations of UCB to the CRO at kick-off and ensure CRO is informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial
Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO
Review and challenge CRO's strategy and plans, if appropriate
Supervise study conduct by regularly reviewing CRO performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact on budget
Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO
Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders
Familiarize with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations
Understand, manage, track and ensure accuracy of study budgets, including the forecast and accrual information
Work closely with the COL (Clinical Operations Lead), Clinical Project Director (CPD), other team members and stakeholders as required and serve as the internal key contact for their assigned studies
Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs and other vendors
Drive the creation of protocol summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may include CRO experts)
Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope
Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members
Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members
Ensure quality and adherence to the relevant UCB SOPs, GCP, regulatory guidelines and working practices. Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner
Provide study specific training for internal (i.e. UCB) and external (i.e. CRO, vendors, investigators) team members
Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs
Travel including overnight stays- possibly global - required
A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience and/or contribute to publications as appropriate
A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel
Perform other tasks as deemed necessary by the Company
A bachelor’s degree required with a Master degree and/or PhD preferred
At least three years’ relevant experience in clinical development including team leadership
Experience or capability to manage in-house and/or outsourced regional or global Phase 2 or 3 multicenter clinical studies from study start-up to study report completion
A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end
Clinical trial management and team leadership
Motivation, mentoring and integration of individuals on multi-functional international teams
Delivery of scientific/medical presentations and training to both large and small audiences
Proficiency in the Microsoft office suite
Scientific and technical knowledge
GCP and regulatory environment
Medical knowledge and research expertise
Basic principles of data management and statistics
Proactive approach, drive and follow through
Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision
Ability to handle detailed technical matters and team dynamics
Reconciliation of conflicting priorities

Clinical Project Manager Resume Examples & Samples

Lead one or more multi-functional, Clinical Study Team(s) or / Joint Clinical Study teams, ensuring effective co-ordination and communication within and across the internal and Partner CRO teams
Work closely with the CPD and other team members as required and serve as the key contact for the assigned studies. Set and manage interface across the internal / external teams: tailor communications interface (meeting frequency, purpose, scope, attendees, reporting...) in-line with deliverables
Ensure that the scope and responsibilities for a study are appropriately reflected in all study contracts and amendments. Articulate study scope, goals and expectations of UCB to the Partner CRO at kick-off
Review and challenge Partner CRO's strategy and plans to ensure study(ies) are delivered to specification, on time and within budget
Supervise study conduct by Partner CRO by regularly reviewing Partner CRO performance through the review of KPIs, metrics and deliverables, focussing on critical activities that might delay the project, jeopardise quality, and/or impact on budget. Proactively mitigate risks; identify potential issues and work with Partner CRO to ensure mitigation strategies for resolution are developed
Ensure a Risk Assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO. Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) or / Joint Clinical Study teams and ensure appropriate actions are taken
Familiarize with the competitive landscape: engage with KOLs, investigational sites, and patient advocacy groups and other relevant organisations
Drive the creation of protocol summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may including from Partner CRO experts)
Collaborate with members of Clinical Study Team(s) or / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents, by providing input and/or approval as defined in Strategic Partner (SP) documents
Understand, manage, track and ensure accuracy of budgets (milestones, pass-throughs, contingency costs and changes in scope). Review changes requested to approved study budgets, identify implications of change and effectively manage the change management process to ensure stakeholder awareness of budget risks
Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data in collaboration with the UCB and/or Partner CRO Clinical Study Team members
Provide study specific training for internal (i.e. UCB) and external (e.g. CRO Partners, vendors, investigators) team members
Identify issues/gaps in processes and interfaces and contribute to developing recommendations for resolution and process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs
Closely cooperate with Outsourcing & Contracts Department and if applicable relevant committees/governance bodies and/or CQA regarding the performance and quality of work received by vendors
Ensure that the study is audit/inspection ready at all times and any result findings from audits/inspections are addressed appropriately and in a timely manner or the oversight of these duties performed by the Partner Project Manager
Relevant Bachelor’s degree with a Master degree being preferred
Five or more years’ relevant experience in clinical development including team leadership, including at least 2 years’ experience as Clinical Project Manager with a proven record of success
Experience to manage outsourced global Phase 2 to Phase 4 multicenter clinical studies from study start-up to study report completion
Substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end
Excellent verbal and written communication in English, time management and organizational skills as well as good interpersonal skills and ability to handle team dynamics
Capability to manage multiple concurrent responsibilities in an environment of changing priorities without close supervision

Associate Clinical Project Manager Resume Examples & Samples

Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biology, clinical research, project management or related field or four (4) years related experience in lieu of degree
A minimum of four (4) years of progressively responsible experience in a project management environment, preferably in a clinical trial/biotechnology/pharmaceutical setting, with an emphasis on coordination of reports, writing and editing
Ability to work in a busy clinical research management setting, both independently and within a team
Excellent oral and medical/technical writing skills
Proficiency in Microsoft Office Suite including Project, Visio, and PowerPoint
Ability to communicate effectively with program leaders
Strong interpersonal, leadership, and analytical skills
Demonstrates good judgement and decision making, attention to detail, personal accountability, administrative abilities, and the ability to handle multiple tasks and priorities effectively
Ability to create and maintain a full spectrum of program/project management documents
Thorough understanding of the clinical research environment

Clinical Project Manager Resume Examples & Samples

Member of the Clinical Trial Team, support the trial Lead to ensure trial deliverables are met according to timelines, budget, quality standards and operational proce-dures
Work with the Trial Lead on investigators meeting organization and all internal meet-ings related to the clinical trial execution and operational excellence
In collaboration with the PLS or Sponsor Medical representative, contribute to the trial data ongoing medical/scientific quality review,
Project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrolment. Develop contingency plans as appropriate
Ensure and sign off high quality Monitoring Plans and other study plans and reports
Work with PLS Line Functions and partners to identify potential operational issues and implement actions to resolve them. Work with PLS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality and deliverables to the next level if no solution can be achieved
Work with Trial Lead and Trial Coordinator for the development, management and tracking of trial budget (internal and external costs) working closely with the PLS Fi-nance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Support the Trial Lead in the preparation and presentation of the trial budget to Sponsor representatives
In collaboration with trial Lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators’ Brochures, brief-ing books, safety updates, IND/NDA submission documents, responses to Health Au-thorities questions, review of clinical trial application packages (as needed)
Fluent English (oral and written)

Clinical Project Manager Resume Examples & Samples

Ability to interact with investigators, vendors, and internal colleagues
Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints
Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner

Biopharmaceutics Associate Clinical Project Manager Resume Examples & Samples

Participate in designing BE studies according to current standards and guidance applicable to conduct of BE studies/clinical studies
Review of regulatory guidance documents and scientific literature to develop the study design. Collect comprehensive pharmacokinetic information for potential drug candidates and to prepare Pharmacokinetic Evaluation as applicable
To review clinical protocols and Informed Consent Forms (ICFs) and Case Report Forms (CRFs) for BE studies/clinical studies
To compile information in support of Clinical Trial Applications (CTA) and Import License applications and to send them to the concerned Clinical Research Organization(s) (CROs)
To supervise and coordinate various study related task from study initiation to closure
To ensure timely shipping of the IMPs to the CRO/clinic site
To arrange for handling, storage and retention of the Investigational Medicinal Products (IMPs), e.g. test and reference products
Review of clinical study reports; ensure eCTD formatting for all documents, prepare clinical documents for ANDA/NDA submissions
University degree in the field of Pharmacy, Chemistry, Health and Science
Ability to multi-task and manage several projects in parallel, paying attention to detail
Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion
Good project planning, negotiation and presentation skills
Excellent interpersonal and verbal/written communication skills
Ability to forge cross-functional working relationships with internal teams and external partners
Ability to resolve routine issues effectively and independently

Assistant Clinical Project Manager Resume Examples & Samples

Establishing clear and measurable timelines, milestones and budget allowances
Experience working with Microsoft Office Programs preferred
1 + years experience working with clinical trials and/or within pharmaceutical environment preferred

Clinical Project Manager Resume Examples & Samples

Responsible for creating and managing timelines for assigned programs while considering strategic objectives and corporate priorities. Work with project team(s) to ensure understanding and buy-in for timelines. Gain approval on timelines from key stakeholders
Routinely monitor progress against program goals. Work with team to develop reporting tools to provide stakeholders with updates on programs. Provide updates to MAF SM leadership on programs and escalate issues that would impede success. Provide updates through presentations on programs to colleagues and management as required
Line management of various levels of clinical research associates (CRAs) as assigned. Oversight for their training and development, performance reviews and work assignments. Functional management of various team members within study management working on assigned programs
Implement processes to ensure deliverables are met within timelines and teams are working according to established plans. Ensure SOPs are followed and team is working in a compliant way to meet program goals. Provide input into new SOPs as required
Oversight for the set-up and management of MAF SM sponsored study documentation in official repositories (e.g., electronic systems). Provide guidance to teams on requirements for the content of the repository per program
Manage vendors across assigned MAF SM sponsored studies; negotiate contracts, budgets and track actual spends against planned. Track program spends against budget; mentor junior staff on budget management; provide MAF SM Directors with updates on budgets for assigned programs. Prepare program budget forecasts under the direction of MAF SM Directors and contribute to long range planning as required
Communicate to team members in a concise and professional manner; ability to influence decision making within teams as well as with management
Effectively manage program specific meetings so that objectives that are established upfront are met; provide concise direction during meetings and ensure actions items are understood
Facilitate short and long term planning for assigned programs. Work with MAF SM Directors on budget planning process for assigned programs. Develop and implement contingency planning with Directors’ support
Assess and appropriately delegate tasks within assigned programs to team members; ensure assigned tasks are progressing according to timeline
Participate in the writing of MAF SM clinical documents, including but not limited to protocols, Informed Consent Form templates, annual reports, statistical analysis plans and study reports
8+ years’ experience in clinical drug development in pharmaceutical or biotech environment
Extensive knowledge of clinical trial documentation including monitoring experience, regulatory agency requirements and operational aspects of clinical trials/registries
Ability to manage the operational aspects of one of more MAF SM sponsored studies
Timeline development utilizing MS Project, budget development experience and a history of line management required

Home Based Clinical Project Manager Resume Examples & Samples

BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience
Moderate clinical research experience in a contract research organization (CRO), pharmaceutical, or biotechnology company
Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, pharmaceutical company, or CRO. Some time must have been spent actively managing clinical research projects across functional areas. Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures
Demonstrated proficiency with ICH/GCP guidelines
Strong presentation, documentation, and interpersonal skills as well as a team-oriented approach
Proficient computer skills in Word, Excel, PowerPoint, email, and Internet. Basic computer skills using MS Project
Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment

Clinical Project Manager Resume Examples & Samples

Communicating job expectations to APM’s
Participating in new hire interviews; provide feedback as directed
Works independently with little to no supervision or oversight, required
Ability to manage projects with increased complexity
Ability to delegate power and authority to a person acting as a representative
Strong client management to minimize non-standard sponsor requests and escalations
2-5 years clinical trials experience within a CRO or pharmaceutical research organization required

Clinical Project Manager Analyst Resume Examples & Samples

Accountable for the coordination and completion of projects that result in new or enhanced clinical abilities yet span multiple UHC functional areas (UHN, HCE, Legal, Clinical Services, Optum, IT) coordination and approval
This position makes recommendations to leadership on people, process and technology changes
Analyze and maintain financial forecast and business planning information for new and existing programs
2+ years of Healthcare experience
5+ years combined business experience in healthcare
2+ years of experience documenting and gaining stakeholder approval on scope definition, project charters and business requirements
Ability to influence peers and leadership across multiple business areas (network, healthcare analytics, legal, clinical SMEs, medical directors and market leadership
Experienced and comfortable presenting project deliverables to leadership both written and verbal
Expertise in areas including project scope definition, business requirement gathering, risk identification, project methodology, resource allocation, facilitation, clinical programs, clinical approach

Clinical Project Manager Late Phase Studies Resume Examples & Samples

Bachelor’s degree is required. Scientific/health care field preferred, but not required
Experience managing GCP studies
Strong organizational, IT and writing skills, as well as strong attention to details
Experience in building relationships with physicians/sites
Experience in overseeing vendors. Ability to communicate effectively and confidently with customers and colleagues at management levels throughout the organization
Flexible, highly motivated to manage projects independently
Ability to motivate, stimulate and communicate across cross-functional groups
Ability to make decisions and take actions on a daily basis consistent with agreed strategy
Ability to streamline processes for highest efficiency

Regional Clinical Project Manager Resume Examples & Samples

Responsible for protocol related targets, objectives and commitments regionally
Leads protocol teams to high performance; supports and interacts directly with CRAs to manage site level activities, interacts and communicates closely with CRM and COM for country timelines and deliverables, and escalates appropriately to CRD to drive efficient study start up, trial execution and closeout across the region. Example of liaising with stakeholders could be; Site selection activities including coordination of site identification, evaluation & validation, in coordination with CRAs and country management. Coordinates validation activities across all involved countries. Work with country data to ensure a feasible and competitive regional proposal. Works with country managements to ensure countries deliverables are ready on time
Responsible for meeting regional targets and objectives for assigned protocols. Drives and tracks protocol deliverables, timelines, trends and performance to meet regional commitments in partnership with countries. It is critical the RCPM manages trials proactively; identifies risks and opportunities early and lead, analyze and prepare mitigation plans and escalate to management. Examples of common problems include 1) low patient recruitment, 2) inadequate sponsor staff to meet business needs, 3) compliance issues and poor study quality, 4) regulatory issues, 5) availability of clinical supplies, and 6) issues related to functional area deliverables that could jeopardize protocol milestones
Must make decisions independently to ensure trials are successful and executed in a compliant and timely manner, with support from regional leadership for key decisions (e.g. change allocation of patients in the region) to ensure regional commitments are met. Provides input to shape regional strategy
Acts as primary point of contact between HQ and country operations in trial coordination and communication. Partners closely with HQ functional areas and builds meaningful relationships and networks. Requires careful coordination and alignment with the regional and broader organization
Interacts and communicates effectively in a culturally diverse remote virtual environment. Facilitates protocol-specific information sharing and best practices across countries. Provides protocol related training and expertise in the region
Coordinates protocol related HQ documents and oversees availability of HQ deliverables and supplies for countries. Collates CTA and other submission documents for the region as applicable. Updates and monitors clinical trial related systems and other protocol tracking tools as needed. Coordinates investigator's meeting activities
Builds a collaboration spirit in a virtual environment and across countries, cultures and functions
Minimum 6 years of clinical research experience
Extensive project management experience required
Expert operational knowledge of how clinical trials are conducted and strong scientific operational understanding
The position requires the ability to follow established processes and protocols and coordinate effectively with internal and external stakeholders
Proven extensive experience with project management with demonstrated success required. International experience will be valued
Excellent communication, educational/pedagogic, interaction, collaboration and organizational skills
Strong ability to lead and coordinate protocol teams to high performance across the region. Requires that the individual has ability to work with a wide range of people across countries in a culturally diverse and remote virtual environment
Requires robust team building spirit with country operations
Ability to proactively develop risk management and mitigation plans across the region in an autonomous way to secure study success
Expertise in core systems and metrics. Requires ability to focus on multiple deliverables and protocols simultaneously
Ability to lead across several dimensions simultaneously
Ability to build understanding of country requirements to proactively serve and coordinate country needs specifically during study start up
Working knowledge of Merck’s core business structure and how own function contributes to and works within the organization
Relationship management and networking: strong integration into headquarter network and ability to build productive relationships with all parties
Ability to prioritize, align and simplify
Fluency in Spanish, French or Portuguese is desirable
Has demonstrated the following leadership behaviors
Ethics & Integrity
Rapid, Disciplined Decisions
Focus on Customers and Patients
Courage and Candor
Drive Results
Build Talent

Senior Clinical Project Manager Resume Examples & Samples

Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures
Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to
Good therapeutic and protocol knowledge

Senior / Clinical Project Manager Resume Examples & Samples

Serving as the primary project contact with the Sponsor (Customer)
Monitoring team performance against contract, customer expectations, and project baselines
Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures

Clinical Project Manager Resume Examples & Samples

Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Regular sitting for extended periods of time
May require occasional travel

Senior Clinical Project Manager Resume Examples & Samples

Thorough knowledge of clinical research process from Phase I through regulatory submission
Ability to manage multiple priorities within a variety of complex clinical trials
Understanding of basic data processing functions, including electronic data capture
Up to 20% travel may be required including international travel
Must be able to secure a credit card cosigned by Novella

Senior Clinical Project Manager Resume Examples & Samples

BSc (or equivalent) in Life Sciences
Previous Oncology experience (essential)
Thorough knowledge of clinical research process
At least 2 years of experience as a successful Clinical Project Manager

Associate Clinical Project Manager for Lilly Resume Examples & Samples

Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance
Provide input for the development of proposals for new work and manage project budgets
Provide input to line managers of their project team members’ performance relative to project tasks
Participate in proposal development and in the bid-defense process with guidance and supervision

Clinical Project Manager Resume Examples & Samples

Knowledge of clinical research process from Phase I through regulatory submission
Ability to manage multiple priorities within various clinical trials
Prior experience in electronic data capture preferred
Experience in contract/timeline management preferred
Ability to travel domestically or internationally as required

Clinical Project Manager, Gcto Resume Examples & Samples

Medical qualifications, bachelor degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science
5 years clinical research experience. 3 years Previous CRA experience desirable and strong organizational skills required
Proficiency in computer skills
Result oriented
Teamwork spirit and cooperation skills
Proactive and self-motivated

Clinical Project Manager Resume Examples & Samples

Support all quality-related activities, including development of project timelines and major deliverables as well as organizing project plans, resource needs, etc
Support QM and QI managers with meeting coverage, data analytics and planning support
Maintain a master Quality calendar for the Agency, including critical elements (who, what, when, why) for every quality deliverable
Assist with evaluation of QM/QI activities, make recommendations for process/project improvement, and develop appropriate reporting mechanisms (such as Huddle Boards) as needed
Requires knowledge of public health system requirements including Medicaid Federal law, Arizona Revised Statute, Arizona Administrative Rules, and AHCCCS policies and contracts
Strong knowledge of all clinical quality management and improvement as it relates to Medicaid Managed Care
Proficient in technical writing skills; oral presentation and research skills; and the ability to synthesize and consolidate technical information
Demonstrated experience with a thorough understanding of policies across multiple functional areas of the agency; oral presentation skills and research skills
Strong ability to interact with internal and external stakeholders effectively to obtain pertinent information for decision making and to communicate directly and effectively
Proficient experience with organizational skills to manage multiple projects simultaneously, prioritize projects and meet deadlines
Bachelor’s degree in Business or Healthcare Management or closely related field and 3-5 years of work experience in healthcare and/or project management

Clinical Project Manager Resume Examples & Samples

Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of trial conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
Assist in the development and design of protocols, CRFs, regulatory documents, study master file, and other study related deliverables
Ensure operational plans are developed consistent with program needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations
Supervise monitors to ensure site visits occur as scheduled and trip reports are accurate and timely; reports to the Sponsor on study progress
Supervise other staff assigned to programs, including clinical site specialists (CSS) and regulatory associates (RA)
Ensure project training occurs
Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
Lead internal client teleconferences and/or meetings and present study information at client meetings, bid defenses and UBC monthly project review meetings
Assist in preparation of client proposals in response to RFPs
Ensure project budget is tracked against contract milestones
Duties described for Project Manager and other duties as assigned by management
At least 5 years of clinical trial experience
Very good supervisory skills
Very good interpersonal skills

Clinical Project Manager Resume Examples & Samples

Manage clinical staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
Manage their project team members’ performance relative to project tasks. Ensure high performance and efficiency of the clinical team through the scheduling of co monitoring/accompanied site/visits and ongoing mentoring of CRA team
Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs
Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable
Identify quality issues within the study to implement appropriate corrective action plans to prevent or correct deficiencies in performance of staff. Escalate findings and action plans to appropriate parties
Serve as primary project contact with Sponsor to ensure communication is maintained and
In depth knowledge of, and ability&skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Strong leadership with excellent organizational and problem solving skills
Excellent customer service skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients

Clinical Project Manager Resume Examples & Samples

Age-related macular degeneration
Conjunctivitis
Glaucoma
Dry Eye
Diabetic macular edema
Keratitis
Experience with Reading Centers (Visual acuity certification, Fundus photography, etc.) and Chart Vendors
Enjoy analyzing complex data, creating execution strategies and presenting in an easily understandable way
Have strong proactive, communication, influencing and negotiation skills
Are emotionally resilient in the face of change
Bachelor’s Degree in medicine, science or equivalent degree
At least 2 years of PM experience for a Project Manager position
At least 4 years PM experience with at least 2 years running large, global trials for Sr. Project Manager Position
Specific therapeutic experience in Ophthalmology as outlined above

Clinical Project Manager Resume Examples & Samples

Rheumatoid Arthritis
Systemic Lupus Erythematosus
Lupus Nephritis
Psoriasis
Atopic Dermatitis
Biosimilars
Specific therapeutic experience in Immunology as outlined above

Clinical Project Manager Resume Examples & Samples

Antibacterial trials with a particular interest in pneumonia and complicated UTI
Global vaccine trials in any age population
Specific therapeutic experience in IDV as outlined above

Clinical Project Manager Resume Examples & Samples

Hemophilia
GVHD
Sickle Cell Disease
Global Rare Disease trials in any indication
Pediatric Rare Disease trials
Specific therapeutic experience in Rare Disease as outlined above

Clinical Project Manager Resume Examples & Samples

Asthma (mild to severe) and COPD – with emphasis on Global Ph II – IIIb trial experience
Cystic Fibrosis – ex-US, CF Foundation experience
Idiopathic Pulmonary Fibrosis
Allergic Rhinitis (seasonal and perennial)
Bronchiectasis
At least 4 years PM experience with at least 2 years running large, global trials for Sr. Project Manager position
Specific therapeutic experience in Respiratory as outlined above

Associate Clinical Project Manager Resume Examples & Samples

Accountable for assigned portion of clinical studies per Contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures
Set objectives of project sub-team(s), according to agreed upon contract, strategy and approach, effectively communicate and assess performance
Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader
Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
Extensive use of keyboard requiring repetitive motion of fingers

Senior Clinical Project Manager Resume Examples & Samples

Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
Participates in study data review and assists with patient narrative writing and other data review activities as assigned
Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports
Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
M.S. and 4+ years of Project Manager experience in a Sponsor or CRO setting, or
B.S. and 6+ years of Project Manager experience in a Sponsor or CRO setting
Broad understanding of operations including those in related development functions
Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
Demonstrates ability to lead multi-disciplinary teams
Hands on Clinical Operations experience
Have lead single or multiple studies

Clinical Project Manager Resume Examples & Samples

Successfully manage the relationship with the sponsor including establishing expectations with deliverables
Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results
Ensure that projects are delivered on-time, within scope and within budget
Communicates with the internal project team and sponsor/vendor project team. Conducts and coordinates team meetings (approves agenda and reviews minutes)
Manage changes to the project scope, project schedule, and project costs including budget management, resource allocation, informing management and client for out of scope activities
Participates in internal project governance initiatives
Measures and reports project performance utilizing key management tools (Risk Management Plan, Project Plan, project reports). Performs risk management to mitigate risks and provide clear direction to team
Reports and escalates issues to management as needed
Plans, develops, and presents meeting presentations and materials for Kick-off Meeting, Investigator Meeting, and Face to Face Meetings
Oversees site feasibility and selection process and consults with the sponsor on the final site list
Forecast investigational product needs; oversee supply chain
Collaborates and works closely with Lead CRA and/or CRA Manager
Participates in Bid Defense and Capabilities Meetings as required
Directs and manages project staff including, training, mentoring, and performance management
Mentors, trains project team members such as PA, CTA I &II, CTM I & II on their roles and responsibilities
Leads or supports Dermatology programs to improve project management processes and tools
Miscellaneous duties, as necessary, in support of Clinical Monitoring and Project Management initiatives, and Dermatology business priorities and objectives
Clinical Trial Managers
Clinical Trial Associates
Project Assistants
College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with related work experience
Advanced knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority
Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint, MS Project
Effective financial management skills
High level of facilitation skills to work with different types of team members
Excellent mentoring and supervisory skills in order to build a staff that works as a team delivering uniform product to each sponsor
Expertise in delivering presentations
Ability for travel (e.g., Investigators Meetings, KOM, FTF)

Global Clinical Project Manager Resume Examples & Samples

Treatment and prevention of seasonal indications like Influenza and RSV
Antivirals for HIV, Hepatitis B or C
Are able to integrate, motivate and lead global cross-functional teams through difficult situations
Are flexible in their thinking
Embrace a can do attitude with each new challenge
Enjoy celebrating each success with their teams
Experience in a Project Manager position
PM experience running large, global trials for Sr. Project Manager Position
Comprehensive knowledge of ICH-GCP
Soft skills required include: excellent communication, planning, decision-making, negotiation, conflict management and time management skills

Clinical Project Manager Resume Examples & Samples

Responsible for managing approved study budget(s)
Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical studies
May mentor more junior Clinical Operations Staff or participate in the onboarding of new personnel
Ensures assigned studies adhere to all applicable regulations and requirements relevant to the study phase, design and/or use of data
Broad understanding of operations including those in related development functions Demonstrates detailed understanding of clinical protocol , intended study populations as well as solid overall drug development
Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
Maintains a flexible, can-do approach to address issues proactively and innovatively
Master’s Degree and 4+ years of relevant work experience
Bachelor’s Degree and 6+ years of relevant work experience
Required Phase IV experience may include
Experience with common Phase IV study types: interventional studies, observational/non-interventional studies, post-marketing requirements, post-marketing commitments, PASS studies, registries, comparative effectiveness studies, etc
Familiar with concepts commonly incorporated into Phase IV studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes/health economics, etc
Exposure to Medical Affairs and publication strategies

Associate Clinical Project Manager Resume Examples & Samples

Create, track and report on project timelines
Produce and distribute status, tracking and financial reports for internal and external team members and senior management
Assist the clinical project manager(s) with budget allocation and approval of invoices
Serve as primary back up project contact with Sponsor and internal project team to ensure communication is maintained and reporting schedules are adhered to
Identify out of scope project work. Escalate findings and action plans to appropriate parties
Coordinate data gathering for the development of proposals for new work
Prepare and present project information at internal and external meetings
Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes
Undertake clinical project management activities as directed by Clinical Project Manager
Train and may coordinate the work of more junior project support staff
May provide direct site support (on site visits)
Understanding of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Basic therapeutic and protocol knowledge

100

Clinical Project Manager Resume Examples & Samples

Responsible for the development of the Project Management Plan that will govern each clinical trial
Accountable and responsible for balancing competing project constraints including scope, quality, schedule, budget, resources and risk
Consulted in the development and execution of clinical protocols, informed consent forms, CRFs, clinical trial budgets, timelines and project plans
Responsible for preparing study specific documents and guidelines and general clinical-related documents
Responsible for the proactive management and conduct of clinical trials according to sponsor protocols and regulations including but not limited to study start-up activities, site selection, initiation, interim monitoring, site management and close-out
Accountable for the management of clinical supply shipments and inventory
As required, manage and track overall study budget, track and administer payments (investigator, DSMB, CEC, etc.), and provide financial reports
Responsible for study tracking, status reports updating project timelines via MS project or equivalent project management tool
Accountable for delivering high quality clinical data according to timelines and within budget for assigned trials
Responsible to ensure sites are ‘GCP’ compliant and following local and regulatory guidelines
Consulted in the procurement process including identification and selection of external service providers (e.g. CROs, DSMB, CEC, etc.), development and negotiation of scope of work, and execution of contract agreements with input from clinical team
Responsible for controlling procurements ensuring adherence to scope of work within timelines and budget, tracking out–of-scope activities and managing / processing change orders
Facilitates communication with all project stakeholders including external service providers, study team, cross-functional groups (e.g., data management, medical writing, etc.) and internal management. Develops practicable solutions to a wide variety of problems
Responsible to organize, coordinate, present and conduct internal team and external service provider meetings as needed
Accountable for the development, planning and conduct of stakeholder training as required
Accountable for the preparation, review and delivery of reports (e.g., interim, clinical study, etc.)
Additional areas of responsibility as assigned
BS / BA or higher in a related scientific area, preferred
Minimum of 5 years related device / pharmaceutical industry experience
Minimum of 3 years clinical trial management experience required
Project Management Professional (PMP) certification preferred, or willingness to obtain within first 6 months of employment
Strong interpersonal skills to competently manage a project including leadership, collaboration, effective communication, decision making, ability to motivate, and trust building
Prior experience in one or more of the following CA Systems is preferred

101

Clinical Project Manager Resume Examples & Samples

Member of the Clinical Trial Team, support the trial Lead to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures
Work with the trial lead on investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence in collaboration with the PLS or sponsor medical representative, contribute to the trial data ongoing medical/scientific quality review
Project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country
Work closely with the regional monitoring managers on trial feasibility and subsequent patient enrolment
Develop contingency plans as appropriate. Ensure and sign off high quality monitoring plans and other study plans and reports. Work with PLS line functions and partners to identify potential operational issues and implement actions to resolve them
Work with PLS clinical data sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality and deliverables to the next level if no solution can be achieved
Work with trial lead and trial coordinator for the development, management and tracking of trial budget (internal and external costs). Working closely with the PLS finance and sponsor representative
Accountable for accuracy of trial information in all trial databases and tracking systems. Support the trial lead in the preparation and presentation of the trial budget to sponsor representatives. Ensure cost reconciliation after trial completion in appropriate payment systems
Work with drug supply management to ensure appropriate planning and of trial medication as well as keep overview of drug availability. In collaboration with trial lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages (as needed)

102

Clinical Project Manager, Clinical Affairs Resume Examples & Samples

Planning: Develop detailed project plans to meet clinical objectives based on cross-functional input and analysis. Through collaboration and influence, gain core team buy-in and team ownership of the plan. Scope: Protocol writing, enrollment, monitoring, data cleaning and lock, biostats, safety, clinical submission deliverables, etc
Requires 5+ years total Clinical Affairs experience in the medical device or related industry, and at least 2 years of experience specifically in Clinical Project Management
Ability to address delicate situations and effectively manage conflict to maximize project team progress
Effect problem solving. Defining problems, developing solutions, weighing options and presenting recommendations
Must be able to interact with high profile investigators in a positive and constructive manner
Travel 10%

103

Senior Clinical Project Manager Resume Examples & Samples

Monitor project schedule and scope to ensure both remain on track. Initiate and implement appropriate actions
5+ years clinical research experience
3+ years experience managing global research studies
2+ years experience working on GI trials

104

Senior Clinical Project Manager Resume Examples & Samples

Manage selection of study vendors for assigned studies
Select investigational sites with input from Clinical Development and vendors
Lead ongoing review of data to ensure quality and consistency
Identify and provide solutions to clinical trial issues or risks
Provide input into non project related activities and development of procedures as requested

105

Clinical Project Manager Resume Examples & Samples

This is an on-site role; 40 hours per week
Will be responsible for meeting/tracking recruitment and study timelines
Setup and run post Market Studies
Independently assess identified risks for escalation
Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO

106

Clinical Project Manager Resume Examples & Samples

Conduct on-site co-monitoring: review overall site performance; ensure investigator’s adherence to protocol and GCP; review Informed Consent Forms, perform source data verification; re-view SAE reports and make sure reporting procedures following to SOP, GCP; collect CRF and review query resolution; review investigational products accountability and review storage condition
Communicate with Global
Oversee appropriate file archiving of all relevant study materials in accordance with local law and Sandoz guidelines
Ensure operational and regulatory integrity of assigned studies and participate in SFDA or other regulatory authority inspections, as needed
At least 4-5 years of Clinical research experiences (global pharmaceutical company experience is preferred)
At least 1-2 years of CPM experiences

107

Clinical Project Manager Resume Examples & Samples

Maintain a basic understanding of the principles of the assay and/or instrument. Remain current with regulatory requirements via professional and educational opportunities
Prepare and/or approve design validation plans; clinical protocols; clinical brochures; case report forms; sample consent forms; statistical plans; and other required documents for clinical studies
Identify and qualify clinical investigators and clinical sites; proposes and negotiates budgets for clinical studies; initiates and track payments to sites and manage expenses within study budget
Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP guidelines and regulations including review of all required essential documents necessary for study initiation and ensure audit ready study files throughout the duration of the study
Conduct site visits to provide training for investigator and staff; determine protocol and regulatory compliance and prepare required documentation ensuring data reported is accurate; complete and verifiable
Maintain and document professional communication with the clinical site; cross functional project team and management throughout the duration of the study

108

Clinical Project Manager Resume Examples & Samples

Drug discovery (eg, Process Chemistry, Analytical Chemistry)
Drug development (eg, Formulation)
Clinical operations (eg, Clinical Project Management)
Supply chain (eg, Clinical Supplies Project Management)

109

RN Clinical Project Manager Resume Examples & Samples

Serve as a Liaison between Health Plan and Business Partners
Project development and oversight
Drive continuous program improvement projects
Provides regulatory education and training to business partners and team members
Review, Analyze and Prepare assigned regulatory reports as required
Problem solve skills: the ability to systematically analyze problems, draw relevant conclusions and devise appropriate courses of action
Excellent verbal communication and business technical writing skills; ability to speak clearly and concisely, convey complex or technical information in a manner that others can understand
Results-oriented, self-starter with ability to learn quickly, adapt to changing priorities and multi-task
Current, unrestricted RN License in the State of Arizona
5+ years clinical, behavioral or case management experience
A background working with the AZ Regional Behavioral Health Authorities

110

Senior Clinical Project Manager, Dermatology Resume Examples & Samples

Previous oncology experience ( essential.)
At least 2 years experience as a Clinical Research Associate/Clinical Monitor, and then at least 2 years as a successful Clinical Project Manager
Demonstrated problem-solving and financial negotiation skills

111

Associate Clinical Project Manager Resume Examples & Samples

Develop and maintain relationships with assigned clients
4+ years of clinical research experience
1+ years experience working on clinical trials in at least one of the following areas: Cardiology, Metabolic, Renal, or Internal Medicine

112

Clinical Project Manager Resume Examples & Samples

Drives all aspects of the project management process from initiation, planning, execution, control and closure.Manages all aspects proactively
Assists in developing protocol concept sheet (study design, entry criteria and schedule of activities table).Reviews protocol and CRFs and tracks development to completion
Creates project budgets and manages cost to budgets.Develops enrollment projection, and drug supply needs as part of the budget
Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project’s progress
Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) and Study Data Sheet for each project
Reviews and approves the site contract template and budget template.Will review and approve any variations to the template
Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process)
Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management)
Reviews study metrics for performance and quality with the team and management
Ensures review of Clinical Trial Master File for completeness
Position has overall responsibility to deliver the projects on time and on budget.The CPM drives study conduct to timely completion in compliance with all regulations and SOPs
Requires the ability to negotiate and manage competing priorities across multiple functional areas
Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects.The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs
Insures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report).Informs all groups of deliverables and timeline, project developments and insures completion according to timelines
Prepares high-quality reports (financial, project, etc.) for management on program status and issues
BA/BS or equivalent is preferred with a minimum of 6 years of pharmaceutical or biotech research experience
Highly effective organizational and communication skills
Proficiency with Excel, MS Project, Contract development and vendor oversight.CRO management experience a plus
Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company

113

Clinical Project Manager Resume Examples & Samples

Serve as key client contact for assigned projects as well as escalation point for CRAs
Create project plans and monitor schedule, scope, and metrics
Proactively engage in both QA and risk management activities to ensure project deliverables are met
Define and manage project resource needs and establish succession plans for key resources
Meet financial performance targets for assigned projects
Prepare and deliver presentations
Ensure efficient cross-functional teamwork among project team members, both internal and external
5+ years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks
1+ years’ experience working with early phase oncology trials (I-IIa)

114

Clinical Project Manager Resume Examples & Samples

Proposals & Implementations: Conducting Request for Proposal (RFP) review and readiness assessment prior to sale, and implementation of contracted clinical requirements prior to go live
Standardization & Alignment: Working with plan acquisitions and diverse business segments to align and standardize processes and assist in the people/process requirements associated with systems alignment and migrations
Remediation & Compliance: Working with functional areas to meet the metrics and performance guarantees required by business and government customers
Coordinate and complete projects and programs across functional areas within defined constraints of scope, quality, schedule, budget, resources and risks
Assist stakeholders in defining performance metrics and capturing project results
Investigate non-standard requests and problems, secure resolution buy-in, and support solutions
Prepare and present project updates, project cycle, and expected results to senior leadership
Ensure project documentation is accurate and aligned with departmental standards
Manage vendors and service providers as needed
BA/BS degree or High School Diploma/ GED with 3+ years of Healthcare Industry Experience
3+ years of experience in tracking, planning projects, working with large data sets and making data-driven analytical decisions
1+ years of experience improving business processes
1+ years of experience in health insurance or pharmacy benefits management
Demonstrated understanding of PMBOK (Project Management Body of Knowledge), Six Sigma, LEAN, and other project management methodologies
Understanding of clinical processes
Experience with MS Project, Excel, Visio, PowerPoint and SharePoint
2+ years of experience gathering requirements
5+ years of managed care experience
Recognized Project Management certification complete or in progress (PMP, Six Sigma)
2+ years of experience in a Project Management Office (PMO)
Demonstrated ability to communicate ideas and project constraints clearly and concisely to leadership

115

Senior / Clinical Project Manager Resume Examples & Samples

Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects
Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team
Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
In depth therapeutic and protocol knowledge
Strong organizational and problem solving skills
Excellent customer service skills

116

Senior Clinical Project Manager Resume Examples & Samples

Shares insights and lessons learned across Clinical Development Execution and exCDE functions to ensure alignment
Master's degree and 6+ years of relevant work experience
Bachelor's degree and 8+ years of relevant work experience

117

Clinical Project Manager Resume Examples & Samples

Lifting -- Not to exceed 50 lbs. -- local practice may apply
Writing
Sitting
Standing
Bending
Vision
Color perception
Depth perception
Reading
Field of vision/peripheral
Fine motor skills
Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline, six years of related experience, with two of those years in project management
Knowledge of FDA, ISO 13485, SOP, MDD standards, and GMP requirements within the medical device industry
Knowledge of Good Clinical Practice Regulations and ICH guidelines
Experience with global clinical trials and vendor management
Experience with managing or mentoring junior staff members
Demonstrated knowledge of regulatory affairs
Demonstrated human relations and effective communication skills -- verbal and written
Excellent oral presentation skills
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Strong organizational skills and the ability to be self-motivated and be detailed oriented
Ability to travel to clinical sites, domestic and foreign, up to 25%

118

Clinical Project Manager Resume Examples & Samples

Leads cross-functional teams and is responsible for the oversight and management of study timelines as well as the financial management of the study(ies)
Contributes to the clinical review of CRFs, completion guidelines, and the data review plan
Leads/assists in the identification and selection of investigator sites
Collaborates with the cross-functional team on selection and potentially management of clinical vendors
Develops and monitors budget for clinical study (investigational sites and vendors)
Responsible for maintaining tracking information in the clinical trial management system Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans
Provide status reports to the Clinical Programs Lead (CPL)
Leads and/or assists the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities
Supports department initiatives and process improvements
Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
Familiarity with financial budgeting and forecasting/reporting

119

Clinical Project Manager Resume Examples & Samples

Provides collaborative leadership and management oversight and coordination for related emerging infectious disease initiatives in support of the VRC
Performs a significant level of project/program management (PM) activities including utilizing PM tools and techniques to organize, plan, execute, report, and evaluate planned program objectives
Manages execution of projects and provides technical guidance in the development of administrative and operational processes, templates, procedure manuals and other documents
Provides managerial support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
Participates in site-assessment activities to examine research competencies and capabilities and provides input for training and capacity building to enhance performance
Provides assistance to clinical research teams in the development of protocol specific plans that adhere to International Conference for Harmonisation (ICH) Good Clinical Practices (GCP), the NIH Standards of Clinical Research, US and International regulations
Interacts with auditing and monitoring agencies to facilitate the exchange of information
Maintains coordination and communication between research operations, program management, and other project stakeholders as well as serves as a liaison with government customers and subcontractors on behalf of the CMRP
Responsible for various subcontract planning, development and implementation activities including preparing statements of work (SOW), evaluating proposals, overseeing budgets and serving as the Technical Project Manager (TPM) for subcontract management oversight
Oversees and monitors the technical work of subcontractors, and performs review and verification of subcontractor deliverables and invoices
Performs a high degree of knowledge transfer related to PM concepts and practices and provides guidance and coaching to team members
Supervises multiple levels of staff
Facilitates communication and monitors team deliverables/action items
Conducts team meetings and assists in the development of meeting agendas
Prepares and reviews progress reports
May travel domestically and/or internationally (up to 20%)
This position is located in Frederick Maryland (telecommuting from East coast may be an option)
Language proficiency in Spanish and/or Brazilian Portuguese

120

Associate Clinical Project Manager Resume Examples & Samples

Manages projects of limited scope (functional or regional). Responsible for project team leadership
Responsible for building and maintaining positive client relationships
Ability to negotiate with clients to assure Novella’s operational processes are maintained, projects are done within scope
Reviewing and identifying project study trends and proactively responding to client and respective team members
Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
Responsible for change management on all assigned projects
Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work
Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
Oversee delegation of support staff activities, as necessary
Assists in the development and delivery of capability and proposal defense presentations to prospective clients
Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team
Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research
Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office
May support Director, Project Management, and Project Management team as required by providing appropriate staff management for awarded programs
Supports Project or Program Managers with directional insight for Change Orders and Out of Scope work; Assists in communication of budget allocations and approval of invoices
Responsible for supporting Project Managers/Program Managers thorough management of project timelines. Assist/Manage in the development of project timelines and milestone tracking
Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate
Participates and assists in the planning and creation of client and investigator meetings and related materials
Authorized to
Good knowledge of clinical research process
Ability to work independently, prioritize and work with in a matrix team environment required
Ability to handle multiple priorities within multiple, complex clinical trials
Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
Extensive working experience with Microsoft Word, Excel, and Power Point
Strong communication skills (verbal and written) to express complex ideas
Ability to set baseline targets, track trends and implement mitigation plans
Working knowledge of current ICH GCP guidelines
Travel may be required, including international travel

121

Clinical Project Manager Resume Examples & Samples

General Medicine (Infectious Diseases, Immunology, Gastrointestinal, Vaccines, Respiratory, Cardiovascular and Endocrinology)
Oncology
CNS
BA/BS in the life sciences, or equivalent combination of education and experience
Previous technical and managerial experience in conducting multi-national and/or local clinical trials in CRO
Presentation, documentation, and interpersonal skills as well as a team-oriented approach

122

Clinical Project Manager Resume Examples & Samples

Manages multiple, smaller IDE and post market studies (within the same therapeutic area)
Has broader knowledge of US and international regulations and standards
Leads Clinical Project Team Meetings. May Serve as Core Team Clinical Representative
Manage CT.gov postings
Key contributor to the development of the CIP, training plan/requirements, and other study related documents. Understands and complies with WI and SOPs
Achieve project quality by ensuring site adherence to the study protocol
Bachelor’s degree required (Biology/Science preferred)
5 to 8 years clinical research experience
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
3 to 5 years study management experience preferred
Experience working in a broader enterprise/cross-divisional business model preferred

123

Clinical Project Manager Resume Examples & Samples

Assist with monitoring CI&A quality improvement and efficiency including identifying opportunities to meet and exceed performance targets
Prepare and ensure agreement on content and timelines for CI&A deliverables during study set up, execution, TLF delivery and study closeout
Document, and track deliverables in the CI&A Tracking SharePoint as communicated to customers
Perform risk based and impact analysis on assigned portfolio projects and provide updates to various consumers
Facilitate requirements gathering from CI&A and P&O colleagues and coordinate solution for data capture, cleaning and processing
Monitor data flow concepts, adjustable study planning execution and data integrity from study start-up to post closure activities
Work with technical colleagues on implementation, corrective and preventative actions, as required
Contribute to the team approach, scope, best practices and responsibilities within CI&A
Understand key clinical trial management roles around data acquisition and processing, statistical analysis and supporting clinical information technologies that support study monitoring and reporting
Understand the activities at the compound, study, and cross study level, including data transformation programming, support of data review activities for study medical experts and data management, and oversight of data exchange with external parties
Understand the operational acquisition of clinical data to ensure that the eCRF and/or eCOA (electronic Clinical Outcome Assessment) tool(s) contains the necessary data to establish the safety and efficacy of the compound being tested Understanding of the process of analyzing clinical data from multiple sources, such as clinical studies, pooled data from various studies, data from CRO partners and from external epidemiology databases
Meet regularly with Process Integration Manager or Integration Expert to ensure adequate communication and support to all GDS&A
Contribute to the team approach, scope, best practices and defined team responsibilities
Candidates with scientific/purely clinical backgrounds that worked in the clinical development process are probably not the best fit as the role is not scientific in nature
This position is a mix of roles but the priority is project management, second is clinical development knowledge, strong facilitator and leader
A strong Project Data Manager might be a good match. The position is more than just knowing data management aspects. Must be able to facilitate discussions and drive results that support the entire clinical development and reporting aspects
Bachelor’s degree (or equivalent) is required; Natural or Life Sciences, Computer Science, Informatics or Business Process related degree
At least 8+ years of HealthCare Industry experience with recent experience in Program/Process/Change Management
Excellence in global cooperation with partnering functional heads
Proven record of successful participation in teams or groups in an intercultural setting
Strong Project management skills, ability to manage globally diverse team members (i.e., highly virtual) to execute key milestones on time
Proficient in Microsoft Office Applications (with a focus on Word, MS Project, PowerPoint)
Knowledge of common Data Standards (E.g., CDISC, CDASH, SDTM)
Understanding of clinical data management (CDM) systems and processes
Understanding of CTM/CDM suite of tools/platforms
Ability to: manage to a specific and detailed multi-dependency compound/project/program deliverables plan; align and manage stakeholders, as well as influence decision makers and stakeholders; manage quality through Risk & Issue Management; and, create, plan and lead the execution of process workshops, meetings and training for Compound and Study Set-up, Execution, TLF’s (SET) team
Strong leadership skills, ability to lead and manage compound team activities by leveraging relationships with key internal/external customers to support business and providing oversight to ensure continuous communication and alignment of major CI&A sub-functions
Working knowledge of the drug development lifecycle focused on data supporting events around the following areas: Study Start Up, Study Build, Study Execution, and Study Close
Minimal travel, may require international travel

124

Clinical Project Manager Resume Examples & Samples

A minimum a Bachelor’s degree or equivalent in Sciences and or Clinical/Technical field in Healthcare (e.g. RN) is required, an advanced degree is an asset
A minimum 5 years’ relevant experience in clinical development, trial management, study monitoring and or R&D in device/pharmaceutical/biotech is required
Sound knowledge of ICH-GCP, FDA and Health Canada regulations
Ability to work independently and in a project team environment
Knowledge of ISO-13485 is highly desirable
Ability to assess external clinical studies/publication and its relevance to company products is required
Bilingual (English/French) is an asset
Health Outcomes research experience is an asset
Experience in monitoring, data management and statistical analysis is an asset
Experience with audits (company and regulatory) an asset

125

Clinical Project Manager Resume Examples & Samples

Lead core project team(s) and facilitate team’s ability to lead extended / complete project team(s) ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director
Provide project focused leadership across Covance departments, offices, external vendors and clients to deliver corporate and department objectives
Serve as escalation point for project issues
Proactively identify and resolve conflicts as needed
Lead implementation of process improvement initiatives on projects as requested
Monitor project scope, schedule and costs to ensure all remain on track with the contract. Initiate and implement appropriate actions if needed to get or stay within contract terms
Proactively lead both quality control and risk management activities to ensure project deliverables are met according to regulatory, client, and Covance requirements
Create required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary
Proactively manage variance to project plans to bring the study back in line with stated project standards. Monthly metrics reports will be reported accurately and on-time to assist in maintenance of project standards
Use lessons learned effectively and contribute to the PMO lessons learned on projects
Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract
Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
Meet financial performance targets for assigned project(s). Accountable for budget control across assigned project(s) and accurate month-to-month completion of earned value analysis, as assigned, and evaluation and management of billed time to plan to minimize write-off and capitalize on fixed-price gains. Proactively identify out of scope activities and execute necessary change orders prior to out-of-scope work being done. Proactively identify project inefficiencies and address issues proactively to stay within budget
Ensure project procurement needs are managed appropriately and per Covance SOPs
Collaborate with finance to initiate monthly invoicing for both service fees and pass-through costs ensuring budgets for both remain within contract terms
Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOPs and are working within the assigned allocation
Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a Project Director
Provide performance feedback of team members to respective line managers and engage line management in problem resolution
Present at external and/or internal meetings
Define and manage project resource needs as appropriate for the phase of project, ensuring that staff are on-boarded to the project just-in-time and are released from the project when work is completed. Establish and ensure execution of succession plans for key resources
Responsible for appropriate issue escalation to appropriate stakeholder(s) inclusive of CAIR and CAPA completion as required
Serve as key client contact for assigned projects
In collaboration with relevant departments, contribute to formulation of the delivery strategy assumptions within your area of expertise and as requested. Ensure costing and the payment schedule is in accordance with the delivery strategy prior to contract execution
May have line management responsibilities for the recruitment, training, utilization, development and performance review of assigned staff
Meet resource management and utilization targets for assigned staff
Ensure lessons learned are implemented across projects currently being managed
Assist in the development, and implementation of study training plans and execution of training
Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility
In lieu of the above requirement, candidates with > six (6) years supervisory experience in a heath care setting and > five (5) years clinical research experience including two (2) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered
Experience in managing global projects with moderate financial value
Ability to utilize resources effectively on moderate scope projects
Financial awareness and ability to actively manage financial tracking systems including moderate projects
Demonstrated ability to lead by example and to encourage team members to seek solutions
Experience mentoring junior level staff
Ability to negotiate and liaise with clients in a professional manner
Ability to assess technology alternatives and implications. In line with relevant functional areas

126

Clinical Project Manager Careallies Resume Examples & Samples

Leads and manages large scale cross-functional compliance projects and company-wide improvement initiatives
Directs multiple teams of business subject matter experts involved in the evaluation of business requirements or may direct a broad range of functions in support of compliance activities in a matrix environment
Partners with Enterprise Compliance to ensures business requirements align with overall strategy
Acts with a sense of urgency to research questions or issues and follow-up with the appropriate parties to drive resolution
Operates and navigates ambiguous and changing situations effectively
Creates and maintains strong working relationships with internal matrix partners
Ensures the timely and quality development and distribution of all deliverables for assigned projects
Drives decision making and escalation of risks or issues
Implement project governance (meeting cadence, project documents, status reporting)
Develops and implements communication and reporting mechanisms to manage issues, risks and timely delivery of results
Prepares and distributes clear and concise issue summary communications via appropriate channels
Works closely with Quality and Accreditation team to meet guidelines for highest quality of service to customers
Active participant and lead on the compliance team
Participate in (LMI) Legislative Mandate Information meetings, policy meetings, Utilization Management/Case Management policy subcommittee meetings, and any other meetings within Cigna and QANI deemed appropriate

127

CRD Associate Clinical Project Manager Resume Examples & Samples

Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Attend bid defense presentations in partnership with Business Development and senior project leader as needed
Provide input to the development of integrated study management plans with the core project team and/or sub-team
Monitor progress against Contract and prepare/present project and/or sub-team information proactively to internal stakeholders
Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts
Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans
Serve as primary or back up project contact with Customer
Lead the efforts of a project sub-team; responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles
Support the project leader in ensuring the financial success of the project
Understanding of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Good understanding of contractual obligations and implications
Good understanding of project financials
Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively
Strong communication and presentation skills, including good command of English language
Bachelor's degree in life sciences or related field and 3 years clinical research experience; or equivalent combination of education, training and experience

128

Senior Clinical Project Manager Resume Examples & Samples

Accountable for the writing of clinical protocols and related documents (i.e. risk management plan) in collaboration with the PLS or Sponsor Medical representative as appropriate
Lead the Clinical Trial Team and assigned resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
In collaboration with the PLS or Sponsor Medical representative, lead the clinical trial or non-intervention study data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
Work with PLS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with PLS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance
Advanced degree or equivalent education/degree in life science/healthcare is required
10+ years’ Clinical Operations experience with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization preferably with significant exposure to the management and conduct of non-interventional studies

129

Bexm Clinical Project Manager Resume Examples & Samples

Work experience in cGMP Manufacturing, Technical Support or Process Development of processes for manufacturing of viruses and/or therapeutic proteins in mammalian and/or microbial systems is required. Knowledge of regulatory guidelines and requirements is a plus. Experience with viruses is highly desired
Excellent client-facing and internal communication skills as well as excellent written and verbal communication skills. Able to effectively transfer complex knowledge regarding science and engineering procedures
Solid organizational skills including attention to detail and ability to manage multiple projects
Strong working knowledge of Microsoft Office software (Word, Excel, PowerPoint, MS Project, SharePoint, etc.)
Proven working experience in project management in the biopharmaceutical/ biotech sector or related field preferred with understanding and/or hands-on experience in project management software and related tools
Successful track record in execution and completion of objectives
Ability to apply technical and cross-functional expertise to address complex operations problems. Demonstrated analytical and creative problem-solving skills
Ability to lead teams and to work effectively with cross-functional & multi-location teams
Experience of a culturally diverse workplace through international projects or global teams is highly desired
Experience negotiating supply agreements with CMOs is a plus

130

Clinical Project Manager Resume Examples & Samples

As the primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships
Managing protocols, scope of project and project components, budgets, timelines, deliverables and quality guidelines thereby ensuring that expectations are met while identifying and mitigating risks
Contribute to strategic relationships and may assist in the development of KPI
Leading bid defense and other business development activities
Managing the project team in a matrix environment
In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered
Ability to work with minimal supervision
Good planning and organization skills
Ability to resolve project-related problems and prioritizes workload for self and team

131

Clinical Project Manager Resume Examples & Samples

7+ years of progressively successful experience in Clinical Affairs and/or Regulatory Affairs
BS Degree in Science, or equivalent
Previous Class I/Class II Medical Device experience
Previous FDA submission and clinical trial experience
Working knowledge of FDA and ISO Regulations
Global product knowledge, re: clinical applications for imaging technologies
Experience in clinical trials and development of clinical protocols and investigations
Problem solving skills for regulatory, quality and safety issues
FDA PMA submissions and management experience
30% Travel

132

Clinical Project Manager Resume Examples & Samples

Familiarity with redcap and biobank (open specimen) a plus
Strong excel data skills (excel, SAS, R, etc.)
Function as primary contact for sites for system and training concerns
Ability to manage meetings
Prepare agendas and minutes
Site training on data systems and protocol
Experienced with IRB process
Review of ICFs for compliance with genomic sharing information
Issue data queries and work with sites to resolve
Create and monitor site /study progress reports
Work with sites to clean data
Work closely with Disease Focus Group Chairs (DFG) on preparing reports
Prepare ad-hoc reports for meetings
Assist in group presentation preparation, as needed
Coordinate minutes for DFG calls and assist in planning agendas
Setup and run national coordinator calls
Coordinate with central repository to maintain site supplies
MS/MPH (Biostatistics/Epidemiology preferable) required
3-5 years’ experience as coordinator or research assistant
Must have sound interpersonal skills
Ability to work with a diverse constituency, handling sensitive and complex information
Ability to prioritize tasks and set deadlines
High degree of computer literacy, especially with Microsoft Office software including Excel and Powerpoint
Ability to learn project management software and online web portals for Partners and NIH
Ability to demonstrate professionalism and respect for individual needs

133

Clinical Project Manager Resume Examples & Samples

Ability to work independently in a complex matrix environment (including remote). Good project management skills
Deep understanding of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
Demonstrated presentation, negotiation and conflict resolution skills
Ability to resolve issues with minimal supervision and understand when to call out

134

Clinical Project Manager Resume Examples & Samples

Provides collaborative leadership and management oversight and coordination of research projects and other initiatives in support of the VRC
Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
Participates in the execution of projects and provides technical guidance in the development of administrative and operational processes, templates, procedure manuals, and other documents
Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
Monitors progress against plans and key deliverables
Manages project risk by proactively anticipating issues and develops contingency plans and solutions
Provides assistance to clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as liaison between government customers and subcontractors on behalf of CMRP
Is responsible for various subcontract planning, development and implementation activities, including preparing statements of work and evaluating proposals
Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members
Travels internationally (approximately 10%)
Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education)
Extensive experience in contract management and reporting
Must be able to obtain and maintain a clearance
Ability to speak, write, and understand Latin American Spanish and/or Brazilian Portuguese a plus

135

Clinical Project Manager Resume Examples & Samples

Manage the vendor(s) throughout the life of assigned clinical trial(s)
Review and refine Clinical Operations Plans including study monitoring and other plans
Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs
Plan and conduct investigator meetings and ad boards, etc
Oversee the submission of trial-related and essential documents to the Trial Master File
Mentor staff and serves as a resource for new employees
Provide or facilitate training to clinical study teams on protocol specific topics
Participate as appropriate in internal and external audits

136

Clinical Project Manager Resume Examples & Samples

Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) to ensure study deliverable are met according to timelines, budget, quality standards and operational procedures
As applicable, directly interact with investigator sites and CRAs/CROs/vendors to en-sure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution
In collaboration with the PLS or Customer data review team (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific quality review to ensure high quality data are transferred/available in a timely manner
Work with Sr. CPM (where applicable) and COS for the development, management and tracking of study budget (internal and external costs) working closely with the PLS Finance and customer representative. Responsible for accuracy of study information in all study databases and tracking systems. Responsible for (or support the Sr. CPM where applicable) the preparation and presentation of the study budget to customer representatives
3 - 6 years’ experience working in clinical study management preferably in early phase/drug discovery

137

Associate Clinical Project Manager Resume Examples & Samples

Provide internal support to PM / PD as a project resource supporting internal systems and systems set-up but also executing day-to-day data analysis of the operational study status reporting activities
Preparation/finalization of project documents, project plans, and status reports
Preparation/finalization of all project plans
Preparation of project Microsoft Project (MSP) timelines
Prepares draft/final weekly/monthly project reports
Support PM/PD in implementing, reviewing, updating project specific metrics, tracking, and reports
Compile draft/final study manuals and all study-related materials
Arrange project related training and trainings overview and records
Assist PM/PD with review of essential project documents
Assists in maintenance, quality control, distribution, and archiving of project documents and reports
Responsible for project TMF preparation, maintenance, and archiving
Responsible for preparation, set-up, review of Management Systems, including CTMS, eTMF, web portals, project-specific logs
Support PM / PD in set-up of a study specific site/vendor payment procedure
Assist PM/PD in ensuring project budgets are tracked against contract milestones
File, track, and log all project invoicing (sponsor, sites, vendors)
Organizes and schedules project team and client meetings
Prepares and distributes draft meeting agendas and minutes for project team review
Support PM/PD to manage 3rd party vendors (answers queries, provide study updates, etc.)
Support PM / PD in appropriate selection of 3rd party vendors and manage procurement process
Facilitates communication among team members
Communicate with the client on specific items as directed by the PM/PD
Lead internal project meetings as directed by PM/PD or dictated by project scope
Perform project management related quality checks in co-operation with PM/PD
Attend project specific training as required
Support PD/PM in preparation for all project audits
Complete routine administrative tasks in a timely manner (e.g. timesheets, expenses)

138

Senior Manager, Clinical Project Manager Resume Examples & Samples

Acting as the primary point of contact for the operational execution of assigned clinical and/or non-clinical studies, Phase I-IV
Delivery of study through oversight of chosen CRO(s) and interface with internal resources for appropriate facets of the operational execution and delivery
Oversight of day to day operational activities of clinical projects
Ownership of study risk management plan including timely communication of study progress, risks and risk mitigation strategy to Programme Leadership
Tracking study progress against the study schedule as detailed in the Integrated Programme Plan
Managing study costs against budget and providing budget forecast data as required
Contribution to and review of key clinical documents, in close collaboration with other line functions e.g. Regulatory Affairs, Clinical Supplies, Clinical Development Pharmacovigilance
Providing input to the preparation of regulatory authority submission documents e.g. IND,CTA, ANDA, MAA and supporting regulatory defence activities as needed
Minimum of a Bachelor’s Degree in a Scientific Discipline or equivalent
Demonstrable experience of working in a clinical project management field within the Pharmaceutical or CRO industry
A combination of experience and/or education will be taken into consideration
Requires strong understanding of the drug development process
ICH GCP Practitioner and working knowledge of other associated regulations, guidelines and industry standards for clinical trials
Experience in managing schedules, budget, risk and processes with a clinical trial setting
Good organization skills, attention to detail, ability to work as part of a global team and the ability to manage multiple tasks is required
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems
Be prepared to travel domestically and internationally for business as required
Proficiency in speaking, comprehending, reading and writing English is required

139

Senior Clinical Project Manager Resume Examples & Samples

Agree with customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved
Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) to ensure study deliverables are met according to time-lines, budget, quality standards and operational procedures
As applicable, directly Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution
In collaboration with the PLS or Customer data review team (Central data Moni-tors, Data Managers, Statisticians, and third parties), contribute to the study da-ta ongoing medical/scientific data quality review to ensure high quality data are transferred/available in a timely manner
Coordinate the data analysis and interpretation for first interpretable results (where applicable) with the PLS or Customer Medical Representative
Accountable for the writing or contributing to the development of Clinical Study Protocol, amendments, Informed Consent Form and other study essential documents, and contributing to clinical sections of regulatory documents (Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages) as required; obtain approval from customer. Responsible for Clinical Study Report either directly contributing to or managing the report writing, or by liaising with the PLS or customer medical writing/narrative group to ensure report is completed according to current requirements
In partnership with Clinical Operations Specialists (COS) (where applicable) accountable for the set up and maintenance of the Trial Master File (TMF) and Clinical Trial Management System (CTMS) for studies
Accountable for working with CTT and QA to identify potential issues and implementing actions to resolve them
Accountable for the development, management and tracking of study budget (internal and external costs) working closely with the PLS Finance and customer representative. Accountable for accuracy of study information in all study data-bases and tracking systems. Responsible for the preparation and presentation of the study budget to customer representatives. Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab)
10+ years’ Clinical Operations experience with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical company or contract research organization
Thorough knowledge of Good Clinical Practice, clini-cal study design, statistics, regulatory processes, and global clinical development process
Ability to resolve issues with minimal supervision and understand when to escalate
Expert skills to facilitate/optimize contribution of team members
Willingness to act accountably in project / study management

140

Clinical Project Manager Resume Examples & Samples

Identify and assist in the development of future business processes to include modifications needed for functional designs in order to enhance functionality of reporting and tracking for financial systems
Provide oversight for record keeping, data collection, management and analysis as well as preparing and presenting program reports
Develop financial management systems application to organization-specific needs and processes; assist in modifying functional designs to enhance functionality of reporting and tracking
Research regulations and law related to interprofessional clinic and telehealth services
Supervise, train, schedule and evaluate professional, research, clinic and/or clerical staff
Oversee day-to-day operations of various projects and grants, interface with interprofessional healthcare teams, state agency funders, and ensure compliance and reporting requirements per project deliverables
Skill in strategic and analytic thought with an ability to solve problems and make decisions
Skill in establishing and maintaining effective working relationships
Excellent oral/written communication and interpersonal skills
Ability to prioritize, plan, and execute multiple complicated and continuing contract and grant assignments in a timely manner
Working knowledge of word processing and spreadsheet computer software packages and financial systems
Knowledge of financial systems applications and accepted business process and practices
Knowledge and management of project management tools and resources

141

Senior Clinical Project Manager Resume Examples & Samples

Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s)
Drives all aspects of the project management process from initiation, planning, execution, control and closure. Manages all aspects proactively
Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget
Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to drive and track a project’s progress
Responsible for creating Project Plans (e.g. Roles and Responsibilities, Communication Plan) for each project
Develops Risk Assessment Plan in conjunction with all team members to proactively identify risks and contingencies
Reviews and approves the site contract template and budget template. Will review and approve any variations to the template
Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management); works with QA to ensure a QA plan is written
Responsible for periodic (weekly, or as needed) clinical trial team meetings
Ensures review of Study level Clinical Trial Master File for completeness
Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs
Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs
Insures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report). Informs all groups of deliverables and timeline, project developments and insures completion according to timelines
Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each
Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
BA/BS or equivalent with at least 8 years of pharmaceutical/biotech clinical development experience or equivalent. An advanced degree (Master’s or PhD), oncology/hematology clinical trial experience, and NDA/BLA filing experience are preferred
Experience must include Phase I-III trials, CRO management, significant experience managing international clinical trials, and project and contract management
Expertise with MS Project and Excel; Project Management Certification (PMP) is suggested
Demonstrated ability to manage and coordinate senior level scientific management personnel and to resolve project issues across organizations
Excellent communication, leadership, conflict resolution, risk management, delegation, decision-making and documentation skills
Ability to apply project management disciplines, including adherence to corporate financial plans and operating strategies and the ability to direct the actions of project team personnel as appropriate
Demonstrated ability to think and act strategically, tactically and operationally as well as proven ability to plan, identify risks, anticipate various outcomes and, balance short-term and long range objectives
Demonstrated expertise of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required

142

Clinical Project Manager Resume Examples & Samples

General responsibility for the independent management and organization of complex customer projects
Direct contact for our customers in all project-relevant questions
Responsible for the smooth execution of customer orders
Involvement of new employees, project managers and PM coordinators
Development of packaging design according to study protocol
Support for the processing of customer requests by Business Development
Coordination with shipping, manufacturing, customer service and quality
Work on strategic concepts for continuous improvement

143

Senior Clinical Project Manager Resume Examples & Samples

Develop and(or) manage contracts, budgets, schedules, and performance requirements
Manage and(or) coordinate the activities of projects with responsibility for results in terms of costs, tasks, methods, resources, timelines and study completion
Function as the main point of contact for sponsors with the FCS project team
Maintain efficient communications among sponsor, clinical sites, and FCS internal functional team members
Regularly communicate and report with senior management on matters concerning resource allocation, project milestones, regulatory issues, project financial performance, and other relevant issues
Direct the setup and maintenance of a Trial Master File at FCS as a repository for study documents
Write and/or review clinical study-related documents including protocol, Informed Consent Form (ICF), and Clinical Study Report (CSR)
Assign and coordinate Clinical Research Associate (CRA) study site monitoring activities
Monitor progress in evaluating, initiating, monitoring, and closing out study sites
Monitor weekly patient enrollment
Monitor overall progress in retrieving/completing case report forms (CRF/eCRF) and data query resolution
Review project correspondence among sponsor, FCS project personnel, and study site personnel
Review monitoring visit reports, and assist in problem solving study site-related issues
Selectively co-monitor at study sites and conduct in-house and on-site training of CRAs for pre-study site evaluations, study initiation visits, study monitoring visits, study close-out visits, and related activities
Coordinate problem solving of diverse scope where analysis of data requires evaluation of identifiable factors
Exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Act as advisor to subordinate(s) and/or mentees to meet schedules, and/or resolve technical problems
Good communication skills with the ability to interface at all levels of management
Manage and foster positive and productive relationship with all project team members and customers of FCS

144

Clinical Project Manager Resume Examples & Samples

Determines project objectives, strategy, scope and schedule to meet business needs
Develops the project Plan in consultation with the cross-functional project team, project stakeholders and the clinical team
Presents project plans, provides ongoing updates, and presents project results to SJM senior clinical management
Assists in the management and execution of the clinical project
Ensures all SJM staff are trained on the requirements of the clinical project and project plan
Responsible for ensuring the clinical project is “audit ready” at all times (project team training records, central files, system validation, etc.)
If applicable, ensures adequate monitoring is conducted on all clinical project
Conducts clinical visits as needed to support clinical project
Enlists support and specifies tasks for various team members to assure meeting objectives are completed on schedule
Provides oversight of clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed
Provides clinical input and support for planning post-project activities and product market launch
If applicable, authors/co-authors project results in medical literature plans and/or presents at scientific investigation meetings
Controls device distribution and allocation
Monitors project reports for accuracy and trending
Provides input to project budgets and project plans
Provide clinical scientific support to project teams
Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions
Develops and implements corrective actions as needed to address any noncompliance issues
Performs LA Reviews of marketing materials related to clinical project
Communicates with and provides updates to specific core teams
Oversees activities delegated by Sr. Clinical Research Manager or Sr. Director, Clinical
Provides input and support for planning post-trial clinical activities and product market launch
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field
Minimum 3-5 years’ experience directly supporting clinical research or similar experience in a medical/scientific area, plus 1-3 years’ experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting
Master’s degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience
High attention to detail and accuracy
Advanced written and oral communications skills
Able to manage multiple tasks
Proficient knowledge of medical terminology
Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA)
Strong problem-solving skills
Advanced knowledge of clinical and outcomes research study design
Demonstrated ability to work effectively on cross-functional teams

145

Clinical Project Manager Resume Examples & Samples

Manage the strategic planning of study conduct in conjunction with product development, ensuring that operating procedures and company policies are followed
Manage study contracts and budgets for clinical trials involving ~100 sites globally
Provide rationale for decisions, present strategies in a clear message and drive clinical study execution with study leads
Mentor/facilitate successful study team behavior
Partner with Clinical Managers to ensure that project deliverables are met
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable regulations and guidelines required to gain approval for clinical trials
10 years’ clinical research experience required, with global involvement
5+ years in clinical operations at the CRO or Sponsor level
Project management experience with negotiation skills is required
Excellent critical thinker and problem solver

146

Clinical Project Manager Resume Examples & Samples

1) Coordinates Documentation by working with the other members of the Project and Study Teams, assures that all critical documentation pertaining to clinical trials is tracked, distributed, and filed according to Standard Operating Procedures (SOPs) and regulatory guidelines set forth by FDA; by attending Project and Study Team meetings and managing critical documents such as agendas, presentations, and minutes; by reviewing regulatory documents for Institutional Review Board (IRB) submissions; by supporting and tracking development of budget proposals and invoice for assigned projects, updating system with invoices for approval, reviewing monitoring reports; and by performing other tasks as requested by the Supervisor."
2) Provides Clinical Trial Project Support "by serving as a key resource to all members of the Project and Study Teams, both internal and external; by administering and tracking clinical trial enrollment for assigned Studies; by assisting in the preparation and tracking of trial budgets; and by performing other tasks as requested by the Supervisor."
3) Performs CRO Coordination by attending regularly scheduled study team meetings; following up on action items, as necessary; by providing feedback, as necessary to CRO staff and other vendors; by tracking an reviewing monitoring reports under guidance of Supervisor and escalates issues, as appropriate; and by performing other tasks as requested by the Supervisor
4) Complies with Regulations "by following all Company procedures to ensure compliance with FDA, GCP, and ICH regulations, federal and state laws, related statutes, and SOPs; and by advising the study team as necessary on matters affecting project success."
1) Performs Planning and Organization by demonstrating strong analytical and problem solving skills; by improvising, troubleshooting, and thinking creatively; and by following Company procedures
2) Keeps Study and Project Teams Informed by creating and submitting regular progress updates
3) Communicates Effectively with Vendors/ Regulatory Agencies by exchanging information through telephone, fax, letter and e-mail; and by following-up as necessary
1) Excellent written and oral communication skills in English. Ability to communicate in pharmaceutical business and elementary scientific technical terms with vendors, consultants, and peers in English
2) Ability to read and write study or project updates, minutes, agendas, and other study or project related documents in English
3) Ability to effectively present information to and respond to questions from the study team and project-related vendors in English
4) Possess a general understanding of the scientific principles used in clinical development process
5) Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
6) "Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists."
7) Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams
8) Must have a general understanding of clinical trial methodology
10) Must have demonstrated ability to work independently, manage time effectively, and handle multiple work pressures
11) Must have experience interfacing and managing multiple vendors/ contractors

147

Clinical Project Manager Resume Examples & Samples

Overall project management of local Medical Affairs studies or the Canadian component of multicentre, international Medical Affairs studies (Phases 3b/4 interventional and non-interventional studies)
Strategic partnering with Medical Affairs, global study teams and key investigators
Accountable to Local Medical Affairs partners and/or global study teams for trial coordination and study deliverables
Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support)
Responsible for local feasibility and investigator selection, study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management
Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial
Audit and inspection preparation
Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement
These positions may require up to 5% domestic and international travel
A minimum of a Bachelor’s degree or RN in Biological Sciences is required
Minimum of three years in Clinical Research including in-house trial management and project management experience with Phase 1-4 trials
Knowledge of several therapeutic areas is required; experience in the strategic management and implementation of local phase 3b/4 and non-interventional trials is an asset
In-depth knowledge of ICH-GCP and Canadian regulations
Strong project management skills with focus on study deliverables, oversight, quality and timelines
Ability to manage complexity; flexible and able to work well in a changing environment
Excellent oral and written communication skills including strong presentation skills. French (written and oral) is an asset
Experience and high proficiency with electronic filing and data systems
Strong attention to detail and focus on quality results
Proven interdependent and strategic partnering ability
Solid skills in the areas of judgement, problem-solving, leadership, analysis, negotiation, and innovation

148

Clinical Project Manager Resume Examples & Samples

Lead, direct, and manage all operational efforts in the development and execution of ISRs supported by Medtronic. This includes but is not limited to managing the grants finance and budget tracking, invoicing and payments, tracking progress at investigative site, developing and managing the internal progress report metrics etc
Manage the ISR Review Process including collection, dissemination, review, approval, notification, contracting, funding, and progress reports
Manage the financial forecasting of the global ISR program budget in conjunction with Finance
Liaise with the Legal department on the coordination and execution of research agreements
Responsible for training cross-functional team members on the ISR processes
Facilitate global ISR review committee
Serves as a member of the Medtronic ISR Council (ISR staff from all regions and business units) and participates in ISR Council Process Improvement efforts

149

Senior Clinical Project Manager Resume Examples & Samples

Identify proactive and creative solutions
Develop talent and lead teams
Drive study completion and deliverables
Ensure adherence to quality metrics
Serve as a partner adding value to the client’s project
5+ years’ relevant clinical research experience
2+ years’ experience of full project management responsibility with at least moderate financial value in global RA trials (preferably early phases)

150

Clinical Project Manager Resume Examples & Samples

Responsible for the planning, implementation, execution and management of one or more complex clinical research studies
Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc
Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required
Leads cross-functional team and is responsible for the financial management of the study(ies)

151

Clinical Project Manager Resume Examples & Samples

Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team
Trains and manages CRO and other clinical vendor activities to ensure the quality meets our client and regulatory requirements
Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact
Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Programs Lead (CPL) as requested
Requests and critically evaluates proposals and change orders from CROs and vendors
Leads team through selection process and provides input into contracts, change orders, and/or work orders
Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or similar
Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines
Ability to interact with investigators, vendors, and individuals at all levels of the organization

152

Senior Clinical Project Manager Resume Examples & Samples

Candidate will have experience in managing some aspects of Registry outcomes from start-up to close-out activities to assure adherence to intended timeline to achieve survey goals while ensuring compliance in accordance with FDA, EMA, GCP, and ICH guidelines
Candidate will have experience in coordinating interdisciplinary activities involving study/site start-up: investigator meeting planning, case report form development, informed consent development, development of contracts and budgets and study manuals
Together with the Registry Lead, create and implement a strategy for the registry
Candidate will support Registry Lead in activities to ensure Global Regulatory Objectives/Commitments are properly prioritized
Oversee contract organizations to help in the execution of the Registries. Contribute with the selection and management of contractors and third parties for work conducted by Shire Outcome Survey group and ensure successful conduct of Outcome Surveys by managing daily activities including timelines to ensure data integrity and quality
In close relationship with the CRO and OS Data Manager, ensure high quality and completeness of the data
May Plan and implement resource allocations (both people and financial) to the individual surveys and activities of the department in collaboration with the Registry Outcomes Team Lead or Registry Lead. Assuring effective resource utilization in line with the department priorities
Work with marketing and commercial colleagues on strategies for supporting products during their life cycle, identifying research to support sales and ensuring its execution
Scientific/health care field preferred but not required
A background with demonstrated success in clinical project management in the pharmaceutical industry
Experience managing GCP studies (both clinical and post-market)
Experience with observational databases preferred
Strong Organizational, IT and writing skills, as well as strong attention to detail
Experience in building relationships with physicians/centers, in particular KOLs
Experience in managing external expert groups

153

Clinical Project Manager Resume Examples & Samples

Responsible for monitoring publication landscape to stay abreast of scientific knowledge and market trends through regular review of scientific literature in order to help develop clinical evidence strategies
Identify evidence gaps or market opportunities to design and execute clinical trials and outcomes research evidence studies with minimal supervision
Contribute to the development and implementation of clinical research strategies to meet business goals and objectives
Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines
Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome
Responsible for conducting clinical studies on schedule and within budget while ensuring high quality and compliance
Participate in data analysis, interpretation and synthesis, instruction in order to develop Clinical study report and /or support development of scientific publications
Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Conduct literature searches, critically appraise scientific literature and write clinical summaries for, products and surgical procedures to assist research and development efforts, to develop Clinical Evaluation Reports, and to develop clinical strategies and clinical investigational protocols
Author, review and revise Clinical Operations Standard Operating Procedures (SOPs)
Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
Provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest) preparation of manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications
Mentor junior clinical project manager (s) on clinical research activities
Assist Clinical Affairs Manager/Director for building departmental process improvement initiatives
Previous experience in industry (medical device, biotechnology, or diagnostics) and experience supporting development of corporate publication strategy
Significant knowledge of clinical and outcomes research study design is necessary
Strong experience in conducting literature searches , reviews and appraisal of the scientific data
Excellent ability to interact with physicians and other professionals inside and outside the company
Possess knowledge of Good Clinical Practice and 21 CFR Part 11 and international regulations
Comfortable in a hospital environment, with experience working with nurses and surgeons (5-8 years)
Strong understanding and background of clinical trials , study design and some formal ICH/GCP knowledge and training
Prior mentoring or supervisory experience preferred, MD, PhD or M.S. degree in scientific field is required
Basic understanding of statistics, statistical methods, and design of experiment is a must
Must have high level of attention to detail and accuracy
Must be able to work effectively on cross-functional teams
Experience in providing work direction for others and have mentoring and interpersonal skills to manage direct reports is desired
Experience in clinical trials. (8-12 years preferred)
Must be able to travel up to 10-20%
Must be able to manage multiple projects across numerous surgical disciplines
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Strong experience in protocol development , writing clinical section for regulatory submission and clinical evaluation report writing
Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary

154

Regional Clinical Project Manager Resume Examples & Samples

Is Accountable for overall management and coordination of protocol related activities across countries within the region in assigned protocols. Acts in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and AE reporting requirements internally and externally
Leads protocol teams to high performance; supports and interacts directly with CRAs to manage site level activities, interacts and communicates closely with CRM and COM for country timelines and deliverables, and escalates appropriately to CRD to drive efficient study start up, trial execution and closeout across the region
Responsible for meeting regional targets and objectives for assigned protocols. Drives and tracks protocol deliverables, timelines and performance to meet regional commitments in partnership with countries.Manages trials proactively; identifies challenges and risks, manages risks and mitigation plans and escalates issues as needed
Acts as PPOC between HQ and CO in trial coordination and communication. Interacts and communicates effectively in a culturally diverse remote virtual environment. Facilitates protocol-specific information sharing and best practices across countries. Provides protocol related training and expertise in the region
A minimum of 8 years of clinical research experience
Requires strategic thinking
The position requires understanding of international cultural diversity and ability to work efficiently in remote and virtual environment
Position requires excellent oral and written English language skills
Strong organizational skills with demonstrated success required
Requires ability to focus on multiple deliverables and protocols simultaneously
Proven extensive experience with project management with demonstrated success required
Site monitoring experience
International experience will be valued

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