Project Manager Clinical Resume Samples

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K Sawayn

Kaleb

Sawayn

465 Abe Spurs

Chicago

+1 (555) 614 4427

465 Abe Spurs

Chicago

Phone

p +1 (555) 614 4427

Experience Experience

Phoenix, AZ

Clinical Trial Project Manager

Phoenix, AZ

Feeney-Howe

Phoenix, AZ

Clinical Trial Project Manager

Work with Business development to devise a transition plan for new accounts to be managed within project management team
Work with Business development and head of region to set KPI (Key Performance Indicators) for key accounts and review on a periodic basis
Develop and execute account management plans for key strategic accounts, with a focus on broadening and deepening relationships
Offer support to Business Development in pursuit of new clients in line with Key Account Management strategy
Arrange and attend clients meetings with business development as and when necessary to aid business review and continual improvement of service
Work with QA, Regulatory and Technical teams to identify opportunities to improve supply chain security, compliance and integrity
Ensure CRM and similar tools are accurately maintained Develop a strong working relationship with internal departments such as Finance and Logistics

Philadelphia, PA

Clinical Denial Project Manager

Philadelphia, PA

Sipes, Ruecker and Kutch

Philadelphia, PA

Clinical Denial Project Manager

Leads/manages medium to large size projects, leveraging basic project management tools to deliver results
Manages all aspects of moderately complex projects
Determines system improvements and implements change
Sets and continually manages project expectations with team members and other stakeholders
Other duties as assigned
Completes audits. Identifies trends
Explores opportunities to add value to job accomplishments

present

Houston, TX

Global Clinical Trial Project Manager

Houston, TX

Hilll-Von

present

Houston, TX

Global Clinical Trial Project Manager

present

Used to working independently and in a team environment, being flexible and adapting in a changing environment
Used to working independently and in a team environment, being flexible and adapting to change
Business-level written and oral English
Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
Track record of successfully managing multiple concurrent global phase I and IIa, multi-country/site complex clinical trials
Interact with investigator sites and CRAs/CROs/vendors to ensure a smooth study set up and a smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised

Education Education

Bachelor’s Degree in Life Sciences With

University of North Texas

Bachelor’s Degree in Life Sciences With

Skills Skills

Experience and demonstrated success in the development and, validation and clinical sample testing by using serology assays and other bio-analytical methods. This includes experience and understanding in working with blood borne pathogens and human serum
Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology
Basic understanding of GMP, GCP-ICH and GCLP guidelines. Understanding of the vaccine development process and experience with the support of clinical trial teams
Fluent English in speaking and writing
Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors)
Strong communication, strategic, analytical problem-solving & interpersonal skills
Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development is desirable, as well as in immunology and molecular biology
Basic understanding of GMP, GCP-ICH and GCLP guidelines
Understanding of the vaccine development process and experience with the support of clinical trial teams
Successful experience in working with globally operating matrix teams and in the coordination with various internal and external interfaces (academia, in-house labs and contracted vendors)

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15 Project Manager Clinical resume templates

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Project Manager, Clinical Diagnostics Resume Examples & Samples

Experience in development of complex products as team member or PM
Experience with IVD Assay Kits is a plus
Experience with Medical Device compliant development methodologies (21 CFR 820, ISO13485)
Excellent communication skills (written, verbal, formal presentation) at all levels of the organization
Broad critical thinking, decision making and judgment skills
Strong interpersonal communications skills
Technical degree in engineering or science (ME, EE, Chemistry, Biology preferred)
5-10 years of related experience in product development with 3 years as a Project Manager
PMP or other formal project management training is preferred
Work experience in the medical device industry or other regulated industry preferred

Global Clinical Trial Project Manager Resume Examples & Samples

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Clinical Scientist for Phase I/II including multi-country / multi-center trials. Your main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration
Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, Therapeutic Area Heads and Project team members
Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc
Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner
Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
(auto) immunological or diseases/conditions related to muscle, connective tissues, joints or bone

Project Manager, Clinical Affairs Resume Examples & Samples

Experienced Program Leader with proven track record of independently,
Passionately and effectively driving the planning and execution of clinical studies
Develops and executes clinical studies which includes the preparation of clinical
Protocols, informed consent forms, investigational plans, study materials (eg,
Training materials, case report forms, study files, supplies requirements)
Establish project objectives and work plans including budgets and resource
Requirements Delegate assignments to functional area team members and track
Key project activities to successful completion
Demonstrate ability to proactively identify and resolve product and project risks
Ensure clinical research is conducted in accordance with FDA Regulations,
GCPs, ICH guidelines, International regulations and internal SOPs
Evaluate and approve clinical sites for studies to ensure compliance with
Applicable regulatory regulations
Manage and oversee site initiation and training to clinical study personnel at sites
Manage on-going monitoring activities: scheduling, report review and approval
Negotiate and prepare study contracts with clinical sites
Experienced leader well-versed in managing within a matrixed organization
Knowledge of FDA Regulations, GCPs, ICH guidelines, International regulations
Experience in management of project risks
Strong communication and teamwork skills
Must possess excellent relationship building skills with team members, peers,
And senior leaders accessing their needs and ask the right questions to surface
Essential requirements information
High degree of competency in Microsoft suite
10+ years of experience in clinical research and project management
Experience leading cross-functional teams and projects
Experience with imaging and/or medical products preferred

Clinical Supplies Project Manager Resume Examples & Samples

Develop and maintain timelines for project deliverables to ensure the availability and timely delivery of clinical supplies
Coordinate with Intarcia’s clinical supply vendors to meet timelines and budgets
Liaise with Intarcia’s internal manufacturing function to communicate clinical supply demands ensure supply
Forecast clinical supplies and ancillary materials and ensure they are managed within set tolerances, including visibility of all stock levels and trigger points
Maintain timelines and information tracking databases
Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs
Provide ongoing support of the IVRS, including ensuring shipment accuracy and tracking, shipment strategy changes, shipment errors (communication between the IVRS & distribution CMO), inventory monitoring, and drug return strategy
Generate clinical label text and design, coordinate label translation and the review and approval of clinical label proofs
Compile all supporting batch documentation, perform technical packaging batch record review and ensure all batch records and other supporting documents are reviewed, approved and released by QA
Participate in and maintain project-related budgets, review invoices and approve payments
Develop or revise Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials
Prefer B.S. degree in Science (minimum)
Understanding of pre-clinical and clinical drug development of investigational new drugs or biologics, familiarity with FDA regulations and guidelines, including cGMPs, cGLPs, and cGCPs, and requirements for INDs and NDAs/BLAs
Exceptionally good interpersonal, verbal and written communication, and organizational skills
A self-motivated team player with ability to motivate others in a team setting
Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment
Ability to recognize and prioritize activities as related to Company programs and to formulate/implement appropriate strategies and actions to achieve Company goals
Must have well-developed desktop computer skills, including familiarity with the use of word processing, spreadsheet, database, graphics and project management software
3 to 5 years direct project management in clinical supplies, working as a member/leader of a project team(s) utilizing internal resources and external contract vendors

Clinical Serology Project Manager Resume Examples & Samples

Support global objectives of Clinical Development and Head of Clinical Serology in VBU
Manage and oversee timely delivery of clinical serology assays of appropriate quality, to assess clinical endpoints in clinical studies of vaccine development, as based on the clinical assay strategy in accordance with regulatory requirements e.g. EMA/FDA guidelines, and quality standards, e.g. Good Laboratory Practice
Collaborate with academia, bio-analytical lab vendors and in-house labs for assay development
Lead serology approach by establishing the Serology Plan reflecting the serology needs of a clinical study, managing operations thereof and seeking for alignment with the Clinical Trial Team
Support drafting and execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans
Oversee and manage the serology budget of clinical sample testing for all studies of the program
Lead sample management during the whole process of the clinical study. Oversee shipment, management and storage of clinical samples
Oversee the review and execution of the Lab Manual for sample management, provided by the contracted vendors. Partner with Clinical Delivery manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines
Inform Quality Assurance team about a quality deviation of sample management and clinical sample testing
Oversee documentation of the above quality deviations in the electronic quality management system
Oversee all timelines of clinical assays: from the development and validation of assays to the delivery of QC/QA results of clinical sample testing to Statistic and Data management. Provide regular updates to clinical teams on status and timelines
Oversee gapless documentation of any documents in the trial master file (TMF) owned by serology in accordance with regulatory requirements and the Takeda Quality management system
MS degree in life sciences with a minimum of 7 years laboratory experience, or PhD in life sciences with a minimum of 5 years laboratory experience
At least 5 years working experience in the pharmaceutical industry, preferably with vaccines
Experience and demonstrated success in the development and, validation and clinical sample testing by using serology assays and other bio-analytical methods. This includes experience and understanding in working with blood borne pathogens and human serum
Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology
Basic understanding of GMP, GCP-ICH and GCLP guidelines. Understanding of the vaccine development process and experience with the support of clinical trial teams
Fluent English in speaking and writing
Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors)
Strong communication, strategic, analytical problem-solving & interpersonal skills

Clinical Trial Project Manager Resume Examples & Samples

Primary interfaces with client regarding project status, budget, scope and issues
Work with the study team to scope required effort and define timelines
Process design - Identify opportunities for process improvements (assess, recommend, and implement recommendations)
Life sciences industry experience and knowledge of clinical trial process preferred (pharmaceutical, biotech, medical device companies, CRO’s and academic & public health organizations)
IVRS/IWRS or EDC experience preferred
Familiar with the SQL, C#, ASP, .NET, and XML technology

Clinical Trials Project Manager Resume Examples & Samples

Working with disease site physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources, anticipate any need for a disease group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
Submitting complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts
Performing group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications
Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed
Work closely with the Regulatory Manager of the CRU to manage review and startup of trials
Working with team members to ensure accurate and timely data entry into Velos (our electronic Clinical Trials Management System), including study status, screening logs, serious adverse events and subject enrollment status
Closely monitoring and reporting to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
Conducting weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed
Monitoring staff workload and work with other disease teams and Administrative Director to share or borrow staff when needed and appropriate. This will include management of staff paid time off
Attending disease group meetings, site initiation visits, and (as needed) monitoring visits

Clinical Pathways Project Manager Resume Examples & Samples

Sustains pathways already put in place by the Department of Quality and Safety
Develops, implements, monitors, troubleshoots, and updates new clinical pathways
Performs medical record chart reviews, abstracts data, and enters data into a data collection tool
Analyzes, reports, and presents pathway compliance and outcomes data
Under the direction of the Sr. Quality Program Manager, collaborates with multidisciplinary leaders throughout BWHC and PHS as well as provides comprehensive program management of clinical pathways
Educates multidisciplinary staff about clinical pathways
Responsible for project logistics such as meeting schedules, agenda development, action item development, production and distribution of meeting materials, pathway correspondence, and preparation of required reports on project status and activities
Assures that project activities are managed consistent with project plans and may execute certain tasks from the plans. Makes effective recommendations to address any barriers or obstacles to achieving project goals. Maintains all relevant project documentation
Bachelors degree required; healthcare related field preferred
1-3 years relevant work experience preferred
Experience working in a large and complex health care organization preferred
Strong computer skills (Word, Excel, and PowerPoint applications), with ability to utilize spreadsheet and graphic programs to produce bar graphs and charts, are required for this position
Superior organizational and interpersonal skills with ability to work independently
Excellent creativity, enthusiasm, and flexibility for developing and implementing new programs
Strong project management skills with experience in planning, facilitating, and organizing improvement programs
Problem-solving ability, data management, and analytic skills
Experience with performance improvement methods
Ability to manage time and resources effectively to meet deadlines
Demonstrated effectiveness as a team member, team facilitator, and team leader
Excellent communication and follow up accompanied by the ability to analyze and present data in a way to influence and change behavior
Comfortable interacting with a vast array of administrative and clinical staff, ranging from frontline providers to senior and executive leadership
High degree of professionalism, discretion, and confidentiality

Clinical Serology Project Manager Resume Examples & Samples

Manage and oversee timely delivery of clinical serology assays of appropriate quality and to assess clinical endpoints in clinical studies of vaccine development as based on the clinical assay strategy in accordance with regulatory requirements e.g. EMA/FDA guidelines, and quality standards, e.g. Good Laboratory Practice
At least 5 years working experience in the pharmaceutical industry, preferably in vaccines
Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development is desirable, as well as in immunology and molecular biology
Basic understanding of GMP, GCP-ICH and GCLP guidelines
Understanding of the vaccine development process and experience with the support of clinical trial teams
Successful experience in working with globally operating matrix teams and in the coordination with various internal and external interfaces (academia, in-house labs and contracted vendors)
Readiness to travel internationally as required
LI-TC2-EUR

Clinical International Project Manager Resume Examples & Samples

Typically have at least 5-7 years relevant project management experience within clinical project management or allied services
Have several years experience in managing late phase trials
Detailed knowledge of project management processes
Working knowledge of timelines and cost estimate development
Robust demonstrable clinical research experience in a bio-pharmaceutical company/CRO including demonstrated skills and competency in project management tasks (i.e. problem solving, communication, presentation, negotiation, team management, etc.)

Project Manager, Clinical Trials Resume Examples & Samples

Independently identify and utilize the appropriate resources to ensure successful project delivery
Ensure project success to final deliverable and review of ongoing projects to ensure appropriate metrics and KPIs are in place to monitor and measure ongoing work
Monitor, coordinate, and resolve problems on projects supported. Project support may include active trial management, kit provision and logistics, sample management, lab services, relocation services, training, on-site management or support of alliances/partnerships
Participate in developing solutions and assisting in the sales process as needed
Effectively interact and communicate with customers (internal and/or external)
Contribute as needed to business needs such as RFPs, project definitions, IT solutions, and develop and implement SOPs and new business processes as needed
Be able to identify customer needs and utilizing available resources and understanding of BST processes, find every way possible to deliver to the needs with efficiency and quality
Develop an understanding and execute the project management role, providing a valuable resource within the organization and ensuring ongoing education and growth about the function of the Project Management to ensure growth of this critical role within the organization
Build, develop and maintain project management tools
Ensure proper scheduling of day-to-day and long range activities and develop and utilize appropriate reporting tools to communicate resource and quality metrics to management
Independently act on client needs to ensure client satisfaction. Communicate to management any recommended process changes to ensure the same
Comply with all company policies and procedures and adhere to company standard of business ethics and conduct
Must be a team player committed to working in a quality environment
Willingly performs other duties as assigned
Travel as needed to support client
Provide support to other departments and functions as needed
Participate in ISISS functional requirement development
BS/BA degree or higher
Approximately three years of applicable experience
Experience in clinical trial management
Experience working in an FDA and GXP regulated environments
Strong organizational skill and good management acumen
Demonstrated ability to collaborate and gain commitment from others
Demonstrated ability to prioritize work, customers, internal and external demands
Superior written and oral communication skills; excellent presentation skills, ability to build credibility with others, ability to engage in effective problem solving conversations

Clinical Serology Project Manager Resume Examples & Samples

Support global objectives of Clinical Development and Head of Clinical Serology in VBU in every aspect of clinical sample testing. This includes but is not limited to reviewing clinical trial lab manuals, preparing Serology Plans to meet the endpoint objectives of each trial, following clinical samples through delivery to bio-analytical vendor, testing, data transfer and long term storage
Actively participate and represent the objectives of Serology and Clinical Development in clinical trial group meetings with the responsibility to follow the big picture and know what impact timeline issues in other groups will impact serology timelines, and also proactively inform other stakeholders when serology timeline changes may impact their activities
Comprehend and translate complicated scientific information in a way that can be utilized by nonscientific members of the clinical trial team
Interpret objectives of other matrix team members in the clinical trial and initiate discussions and collaboration so that what could be conflicting timelines and goals lead to the successful accomplishment of overall study objectives
This now falls more under the interaction between the Serology Lead and Analytical Development group
Drive the drafting and responsible for execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans
Lead sample management for the clinical study beginning with oversight of shipment conditions and timing from the clinical site to the central laboratory, delivery of samples to the bio-analytical vendor, testing, reconciliation, data transfer, and final long term storage or further use approval of clinical samples
Oversee the review and execution of the Lab Manual, provided by the contracted central lab vendors, to guarantee proper sample management. Partner with Clinical Delivery project manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines
Inform Quality Assurance team on any quality deviation of sample management and clinical sample testing
Actively collect, interpret and review and document the above quality deviations for clinical sample handling or testing in the appropriate QA system
Oversee the trial master file (TMF) documents owned by serology in accordance with regulatory requirements and the Takeda Quality management system
Clearly document any changes to the clinical trial assay plan with analytically interpreted risk management assessment of impact to data and overall clinical trial outcomes. Understanding and ability to communicate justification for changes a high priority
Bachelors Degree or international equivalent in the life sciences required with a minimum of 5 years practical laboratory experience. Advanced degree highly desirable with a minimum of 3 years post degree practical laboratory experience
Minimum 3 years demonstrated excellence in project/program management. Preference given for work in the pharmaceutical environment and/or work with vaccines
Knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), and knowledge of cGCP, cGLP and cGMP
Proven leadership, team building skills and strategic problem-solving ability. Demonstrated ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions
Proven ability to communicate and collaborate effectively with senior management. Experience interacting with external collaborators with ability to build strong relationships
Knowledge of risk management, project reporting, and project management tools
Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead highly technical teams
Excellent organization, verbal and written communication skills to explain project goals and inspire support
Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously
Demonstrated time-management organizational skills
Experience and demonstrated success in sample testing by using serology assays and other bio-analytical methods. This includes experience and understanding in working with blood borne pathogens and human serum. Preference if this experience also includes assay development, qualification and validation
Fluent spoken and written English

Clinical Supplies Project Manager Resume Examples & Samples

Provide representation for the Global Clinical Supply Management at R&D meetings, by sharing updates and forecasting the status of various projects
Review and update existing SOPs, organize and conduct meetings, and evaluate customer needs and offer expertise to accomplish project goals
Create and implement timelines and budgets; develop forecasts and compile other requirements for the preparation of Clinical Supply Master Plan, including clinical protocols phases I through IV
Assist in the design of clinical labels, packaging, and in forecasting clinical supply orders
Scientific Degree preferred; Supply Chain and Project Management background helpful
At least three years of relevant clinical or pharmaceutical experience, with knowledge of cGMPs and applicable FDA regulations
At least one year experience with packaging and labeling
Strong leadership, communication, and problem solving skills

Clinical Informatics Project Manager Resume Examples & Samples

Formal project methodology and management skills
Strong communication and management skills
Ability to perform at a high level of effectiveness in a fast pace environment, managing multiple priorities simultaneously
Ability to work with supervisor/manager and other members of section or department to promote a harmonious work environment
BS in Computer Science or equivalent experience in a relevant field
Knowledge of operational workflow in Physician practice setting
Knowledge of clinical work flow in both inpatient and outpatient settings
Athena® certified professional within 6 months of hire
PMI or PMP certification

Meditech Clinical Ready Certified Project Manager Resume Examples & Samples

Ability to facilitate meetings for a large diverse team
Drive decisions to facilitate project progression
Strong consulting background, must be MEDITECH READY Certified
MEDITECH Clinical applications experience
Advanced Clinical experience required
Maintain regular and thorough communication with client, vendor, team members and team leaders regarding project issues, risks, and needs

Clinical Trials Project Manager Resume Examples & Samples

Effectively manage multiple studies and/or programs simultaneously to ensure time, quality, and cost metrics are adequately defined and met. Identify and manage potential risks and impacts with regard to
O Site identification/qualification
BA/B S in related scientific or healthcare field and 6+ years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology and antibody/biologics experience; CCRA preferred
Proven ability to plan, conduct and manage clinical operations from pre-clinical through early phase trials, with additional experience in later phases preferable
Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors
Previous experience negotiating vendor/site contracts and fiscal management thereof
Ability to write and edit protocols and other project-related documents, clinical study reports and summary documents for regulatory submissions
Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment; listens and seeks clarification; responds effectively to inquiries or complaints
Excellent organizational and problem solving skills with the capacity to organize assignments and work within deadlines

Global Clinical Trial Project Manager Resume Examples & Samples

Clinical Scientist for Phase I/II including multi-country / multi-center trials: The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration
Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure that all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members
Lead all aspects of study planning and collaborate with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
Interact with investigator sites and CRAs/CROs/vendors to ensure a smooth study set up and a smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
You may support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc
Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure that high quality data are transferred/available in a timely manner
Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure that reports are completed according to current requirements

Clinical Trial Project Manager Resume Examples & Samples

Key Account Management Champion and deliver world class customer service to clients in portfolio
Develop and execute account management plans for key strategic accounts, with a focus on broadening and deepening relationships
Work with Business development and head of region to set KPI (Key Performance Indicators) for key accounts and review on a periodic basis
Proactively identify organic growth opportunities and coordinate the necessary involvement of all relevant personnel to execute
Arrange and attend clients meetings with business development as and when necessary to aid business review and continual improvement of service
Understand, develop and upsell added value services direct-to-site, DDLD, IITs, ancillaries to key accounts
Demonstrate an excellent understanding of the clinical trial supply chain through working with sourcing and logistics colleagues
Develop an understanding of the key challenges customers face in clinical supply, logistics and services and proactively promote discussion with clients
Utilize all tools, resources and databases at disposal to better understand customer needs
Ensure Procurement colleagues are presented with fully vetted client inquiries so that they may offer the best possible level of service
Co-ordinate with company personnel to ensure timely execution of each project
Proactively keep CRM system up to date with all new, future and existing enquires
Offer support to Business Development in pursuit of new clients in line with Key Account Management strategy
Work with Business development to devise a transition plan for new accounts to be managed within project management team
Interact and coordinate with other Group staff members MA, SP working on same sponsor account to ensure a joined up approach
Use unique positioning of the PM role to identify and share opportunities and gaps in supply chain, systems and processes
Managing, prioritizing, and completing inquiries and projects to a high standard presenting exceptional customer service to both internal and external customers
Build and develop a team of dedicated CT project management colleagues to fit the growing needs of the business
Act as a role model of the company
Values QA, Regulatory Compliance, Ensure all licenses, documentation, audits and associated QA
Work with QA, Regulatory and Technical teams to identify opportunities to improve supply chain security, compliance and integrity
Current with relevant legislation and its impact on business activities
Ensure CRM and similar tools are accurately maintained Develop a strong working relationship with internal departments such as Finance and Logistics

Clinical Affairs Project Manager Resume Examples & Samples

Direct the planning and execution of clinical activities to support the optimal use of currently marketed products, premarket products, regulatory filings and other goals of the Company
Ensure that all project team members understand and work towards the same goals and that the priorities and measures of those goals are understood and accepted. This includes responsibility for the monitoring performance of field CRAs on assigned projects and that the level of accountability is understood and accepted
Develop study materials (i.e., protocols, case report forms, monitoring plans, interim and final reports) necessary for the conduct of quality clinical trials
Creatively apply experience and know-how to maintain timelines and quality (e.g., developing data cleaning and subject retention strategies and inspection readiness plans)
Lead project team meetings and facilitate information exchange among team members to overcome obstacles and build project teams
Lead site identification and selection activities and ongoing site management (including site visits, as necessary)
Oversees device shipments and inventory (including inventory forecasting)
Interacts with team members to ensure all study operational documents, CTMS, Trial Master Files and clinicaltrials.gov content for assigned projects are maintained and documentation is audit ready at all times
Forecast, manage, and track overall clinical trial budgets (headcount and internal/external costs) to maintain or accelerate timelines and ensure fiscal responsibility
Responsible for developing, monitoring and reporting metrics designed to improve and assess trial performance, including speed and effectiveness of site start-up, training, speed and accuracy of screening, recruitment, protocol adherence, data collection and reporting
Pro-actively facilitates clinical study and HCP contracting process between Davol and investigational sites and KOLs
Identification and selection of external service providers (e.g. CROs, Data Safety Monitoring Boards (DSMB), CEC, etc.), development and negotiation of scope of work, and execution of contract agreements
Manages vendor relationships through effective communication and efficient interactions to optimize clinical trial performance and adherence to scope of work (including DSMBs). Ensure adherence to scope of work within timelines and budget, track out–of-scope activities and manage change orders
Create, maintain and grow professional relationships with internal and external partners, including surgeon KOLs
Prepare internal reports and documents of clinical study results that may lead to round table and Scientific Advisory Board sessions to adequately understand the results and to provide clinician access to up-to-date scientific and clinical data
Ensure compliance with company standards, policies and procedures, Good Clinical Practice (GCP), and other applicable regulations
Performs special projects and other duties as assigned
BS/BA with a background in life science, health science, or related field
Minimum of 5 years relevant experience in clinical research including experience managing premarket, randomized, controlled trials, the development of clinical study materials and managing data cleaning activities
Strong project management skills across the full lifecycle of clinical research studies
Development and use of clinical information technology tools (i.e., CTMS, EDC)
Proficient knowledge of Good Clinical Practice (GCP), regulations, and industry best practices related to the conduct of clinical trials
Ability to work in and or create a team-oriented, collaborative environment
Excellent communication skills (oral and written)
Ability to work independently, manage multiple projects and personnel in a fast paced environment, and effectively navigate obstacles
Excellent follow-through capability
Self-motivated, attention to detail and organizational skills
Experience with various computer systems / applications and clinical trial management systems an willingness to learn new systems / databases
Ability to travel up to 20-30%
Prior experience with medical devices and surgical research preferred

Manager, Clinical Project Management Resume Examples & Samples

Review the clinical pharmacy model
Grow the clinical pharmacy business (ProxiMed and CS)
Develop the strategy for retirement residences, medical clinics and other more specialized consultation locations
Lead the operational integration of professional programs in collaboration with the Operations Manager and the Pharmacy Operations Manager, Operational Services
Support the management of the Customer Experience department, Central Ops (Quebec)
Develop and implement a new PROXIM Network Performance department
University degree in administration, project management, communications, etc. (an asset)
Minimum of five years' experience in the pharmacy industry
Experience in project management, business development and team supervision
Driver’s licence and able to travel (15%)
Exceptional aptitude for sales and negotiation
Strong communication, teamwork and team management skills
Able to work with multiple departments and functions
Excellent organizational skills with a disciplined approach and follow-up
Solid interpersonal skills and able to build positive and lasting relationships
Adept at delegating and engaging people
Inspiring leadership skills
Excellent analytical and synthesizing skills
Able to turn strategies into concrete actions
Able to work under pressure and manage multiple projects at the same time
Able to determine client needs and recommend quality, creative and innovative solutions
Discreet and diplomatic
Determined and independent
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint and Outlook)

Senior Clinical Trial Project Manager Resume Examples & Samples

Monitor project status and timelines
Manage clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications
Coordination of site initiation visit/site training
Prepare and process DSMB Reports; Organize and coordinate DSMB Meetings
Reporting of study progress and subject statuses; provide IND summary information for the IND annual report
Review/report the status of case report form completion and data query resolution
Manage/maintain the Sponsor Trial Master Files for each project/site
Bachelor’s Degree with 5-7 years of related experience; or combination of equivalent education/experience
Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies
Previous Project Management experience preferred. The candidate must possess and have demonstrated the following skills
Ability to manage projects independently
Strong problem-solving and organizational skills
Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames

Clinical Trial Transparency Project Manager Resume Examples & Samples

Project Management coordination of Transparency activities under Takeda Policies and Processes: Manages clinical trial transparency activities for all Takeda clinical trials to ensure activities are harmonized worldwide, and comply with all applicable US and international laws, regulations, industry requirements, and Takeda transparency procedures and commitments
Bachelor’s degree in science or communication
Advanced degree preferred (e.g. Science, Regulatory Affairs, Research)
5 years of experience in the pharmaceutical industry or equivalent experience (e.g. academic research, contract research organization, medical writing)
2+ years experience with clinical trial transparency, project management or quality assurance
Solid understanding of clinical development, including the phases, processes, and scientific methodology used within a clinical development program from protocol design through regulatory submission
Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to good clinical practice and clinical trial disclosure
Ability to effectively develop and implement project or compliance plans
Understanding of how to develop, apply and evaluate effectiveness of policies, procedures, and work instructions to ensure compliance to national, international, and corporate requirements for clinical trial trasnparency
Ability to manage contract processing and establish budget and invoice oversight procedures to maintain departments targets
Demonstrates problem-solving and interpersonal skills that facilitate effective interactions within global cross-functional teams and vendor(s)
Ability to identify issues and generate solutions or request appropriate intervention by management
Demonstrates advanced computer software and system skills

Clinical Site Project Manager Resume Examples & Samples

At least 3 years’ experience in customer interaction / consultation for example as an IT Consultant at a Corporate IT company
Ability to build close relationships with clinicians and IT hospital staff
Strong project management capabilities and experience as a Project Manager
Based in NL, able to travel to hospital sites ~60-80% of time
English fluency a must, Dutch proficiency a pro

Project Manager Quoting Clinical Trials Resume Examples & Samples

The approval of the opportunity ensuring all Information is correctly received from the Business Development Managers and Project Managers
Ensuring all data in Salesforce from the opportunity submitted to when the opportunity goes into DocuSign is correctly inputted
Writing the quote in the quoting application and ensuring that data is accurate and maintained
Coordination and communication with all relevant activities, both internal and external to ensure that the quote meets the requirements of the client
Once the Quote has approval from the BDM and PM then the quote will be entered into DocuSign by the Project Manager to be signed by the authorized signatories
Use of appropriate planning tools to communicate milestones and critical path activities and any risk factors delaying the quote
Timely provision of reports and other information required by the management
Completing and complying with the day to day requirements and standards set down by Thermo Fisher Scientific
Other specific activities can include monitoring project activities and day to day business, establishment of a customer approved Job Specification, collection of all the information on a study design, including correct label texts, coordination of primary, secondary packaging material and tools, coordination of label translation with the Labeling Project Manager, producing all batch documentation for operations and check of documentation, coordination of shipments through the logistics department, and writing Distribution orders and GMP instructions in a timely manner
Demonstrate and Promote the Company vision
Clinical trial experience preferred. A minimum of 5 years of successful experience in project management as a Project Manager appropriate position
Basic understanding of Project Management Concepts as a recognized institution in project management (i.e. Project Management Institute)
Experienced in dealing with clients

Senior Clinical Affairs Project Manager Resume Examples & Samples

Provide project support for both US and global clinical trials consistent with applicable regulations, guidelines and policies
Ensure conformance with GCP
Assist in the development, communication, and creation of programs to support company objectives
Investigate issues and propose solutions for improved work processes in various departments
Develop, nurture and maintain relationships with investigators, coordinators, site staff and other members of the ZOLL team
Assist implementing immediate and long-range plans in order to achieve business objectives for clinical trial research in support of regulatory submissions
Ability to simultaneously balance multiple business, clinical, product and physician issues is a key requirement
BS degree in life sciences plus 5 years of related work experience, or equivalent combination of education and experience
Prior experience executing clinical programs in cardiovascular medical devices, particularly interventional cardiology or ICU-based clinical trials, is required
Prior experience managing clinical trial projects and the staff associated with them is required

Clinical Informatics Project Manager Resume Examples & Samples

Acts as a leader and consensus builder for broad, multidisciplinary groups including the clinical community, other hospital departments, and IT analysts as appropriate, clearly communicating and translating information and concepts between and across the different groups and driving outcomes
Creates system specifications and workflow documents for new projects and/or features and maintains/updates existing specifications and project documents for complex clinical initiatives that include technical details, user expectations, project goals, work effort, accountability, and deliverables
Develops project timelines, demonstrating flexibility in adjusting to the fluctuating needs of the department
Identifies system optimization and enhancements and collaborates with vendors and IT analysts in order to design and implement
Organizes, participates in, and frequently leads departmental user groups and other meetings, and maintains appropriate meeting records
Provides oversight to complex projects
Researches issues and uses independent analysis and judgment to produce solution options (including alternative solutions when necessary to address system limitations) to complex and/or controversial matters, including pros, cons, risks, benefits, costs, and unintended consequences
Reviews system configuration and design options in order to make appropriate recommendations for system maintenance requests
Selects and determines optimal solution from among various options, communicates reasoning, and influences others to achieve adoption
Serves as backup to the Director of Clinical Informatics
Collaborates with User Groups to maintain an ongoing understanding of business issues and needs
Creates project organization structure and team composition; facilitates communication between project team members on deliverables
Determine project scope and deliverables, sets project expectations; develops and manages project plans e.g., identification of user requirements, analysis and design, buy/ proposals, contract negotiations, risk assessment, specification development, development and implementation, installation, configuration, testing, training, documentation, policy and procedure development, issue resolution, marketing and go-live customer support
Monitor project schedule and budget; facilitate discussions on the assessment, documentation, and recommendations on business process flow to achieve project objectives
Ability to analyze highly complex systems and workflows
Ability to communicate concepts in elegant, concise, eloquent form to management and to cross-functional departments or teams verbally, in writing, and through pictures or diagrams when appropriate
Ability to conceptualize, plan, organize, coordinate, and manage the work of a major program or function within a department
Ability to influence and to negotiate on behalf of others to achieve best outcomes for the department and the organization as a whole
Ability to lead complex discussions, often on challenging and/or controversial subjects, and drive a group toward consensus in a timely fashion
Knowledge of computer systems and software used in functional area
Knowledge of current issues and trends in health care and clinical operations in a health care system
Knowledge of Epic systems as well as other information systems, clinical software, and computer applications used in a health care setting
Knowledge of medical informatics
Knowledge of redesigning clinical processes to improve efficiency and patient care, preferably in conjunction with the implementation of a clinical information system
Ability to foster effective working relationships and build consensus
Ability to strategize, plan and implement change
Ability to supervise, coach, mentor, train, and evaluate work results
Knowledge and understanding of the integration of information systems with specific organizational business needs and plans

Project Manager, Global Clinical Supplies Resume Examples & Samples

1+ year of leadership responsibility Detailed cGMP, GCP and ICT knowledge
Direct experience with the Clinical Supply process, including manufacturing, auditing, labeling and packaging
Expert knowledge of GMP's and GCP's
Ability to motivate and integrate teams and teach/mentor team members
Ability to discipline and reward employees and perform timely, effective performance evaluations
Effective organizational, planning and negotiation skills
Ability to act as a liaison with other departments where necessary

Project Manager, Clinical Innovations Resume Examples & Samples

Assist Senior and Executive leadership in the identification of performance improvement opportunities within Clinical Operations aimed at improving member health outcomes, reducing inappropriate utilization, and increasing both quality and member satisfaction
Perform research and analysis to determine scope, feasibility, and impact of implementing initiatives. Provide actionable recommendations, create executable roadmap for process redesign and implementation, and identify methodology and metrics for measuring success and monitoring outcomes
Manage initiatives aimed at the re-engineering of operational processes to improve efficiencies within the department, including but not limited to care/case management and utilization management
Re-engineer operational processes by streamlining workflows, improving system functionality, increasing value-add activities and interventions
Builds criteria to systemically evaluate both qualitative and quantitative attributes of new solutions implemented to ultimately measure results and drive additional recommendation to Senior and Executive Management
Define scope and size of new solutions to inform executable roadmap for implementation and process redesign
Key contributor to critical departmental documentation, including policies, procedures, process maps, training materials, and audit tools
Represent the department through participation in organization-wide strategic initiatives, collaborating with other operational areas to ensure successful implementations
Provide strategic project leadership and management in implementation of new solutions and capabilities
Self-motivated and able to work collaboratively as a member of a team as well as on one’s own as needed

Project Manager, Clinical Innovations Resume Examples & Samples

BA/BS – Bachelors Degree or equivalent required
MA/MS - Masters Degree or equivalent strongly preferred
Five to eight years related experience required
Proficiency in Microsoft Office: Excel, Word, Access; Internet

Project Manager, Clinical Business Strategies Resume Examples & Samples

Master’s Degree in Policy, Public Health, Anthropology, or Demography
3-5 years of experience in health care policy, public health, or consulting
Demonstrated ability to utilize statistical software, including SAS
Demonstrated ability to utilize spatial analysis software, including ArcGIS 10.X
Demonstrated ability to utilize software development and data query language, including SQL
Demonstrated experience related the development, implementation, and enhancement of new projects based on customer needs
Demonstrated experience related to the evaluation of projects throughout the various phases of an offering, including newly launched offerings to mature offerings

Clinical Denial Project Manager Resume Examples & Samples

Manages all aspects of moderately complex projects
Leads/manages medium to large size projects, leveraging basic project management tools to deliver results
Prepares and completes action plans Implements production, productivity, quality, and customer-service standards
Enhances department and organization reputation by accepting ownership for accomplishing new and different requests

Clinical Trial Project Manager Resume Examples & Samples

Advanced degree in medical/pharmaceutical discipline, project management or business is preferred
Knowledge of FDA, CIRM and Stanford processes, regulations and procedures
Ability to produce Gantt Charts for project management
Firm understanding of the research process including but not limited to; the development of protocol, implementation of a successful research project, and management of RA’s using project plans and coordinating teamwork assignments in the field
10 or more years of relevant work experience – i.e., in clinical research, device development, pharmaceutical industry etc
5 years of team lead project management experience in a CRO or device/pharmaceutical setting
Relevant work experience at an academic institution
Ability to manage multiple priorities in a fast-paced, deadline-driven environment
Demonstrated solid planning and organizational skills
Excellent interpersonal, written and oral communication skills