Director, Clinical Operations Resume Samples

4.6 (122 votes) for Director, Clinical Operations Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the director, clinical operations job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Resume Builder
CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Create a Resume in Minutes
JW
J Wilkinson
Jessy
Wilkinson
47083 Abshire Stream
New York
NY
+1 (555) 565 0846
47083 Abshire Stream
New York
NY
Phone
p +1 (555) 565 0846
Experience Experience
Houston, TX
Director Clinical Operations
Houston, TX
Skiles-Ullrich
Houston, TX
Director Clinical Operations
  • The Director will provide assistance, expertise and direction to promote the effective operation of the clinics including
  • Participate in policy making and administrative problem solving through active representation in hospital administrative meetings, departmental meetings and physician meetings
  • Provides direction to committees and teams within the department and shall participate in hospital committee functions
  • Provides and serves as a resource to the Chief of Staff, Department Chairs, and functional team chairs
  • Attends department/section meetings, as possible, to facilitate communication and encourage consensus on goals of the clinics
  • Shall serve as a liaison between the hospital and the physician’s medical practices
  • Monitors, evaluates and attends to all physician and patient complaints
Phoenix, AZ
Director, Clinical Operations
Phoenix, AZ
Hettinger Group
Phoenix, AZ
Director, Clinical Operations
  • Leading the overall delivery, through your management team, to drive execution of service, client satisfaction, quality and efficiencies
  • Ongoing assessment, evaluation and management of internal and external resources
  • Developing key relationships with the wider business both locally at country level and through the global function, in particular global project management
  • Clinical outcomes consistently ranked above the national average
  • Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors
  • Manage the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs). Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug supplies, etc.)
  • Operational oversight of one or more clinical development programs. Plan and initiate clinical trials including protocol development; evaluation of investigators; evaluation, selection and training of CROs including monitors; review and negotiation of study budgets; CRF design coordination; Direct the planning and execution of all operational activities involved in area of specific therapeutic indication
present
Philadelphia, PA
Senior Director, Clinical Operations
Philadelphia, PA
Erdman, Feest and Durgan
present
Philadelphia, PA
Senior Director, Clinical Operations
present
  • Provides strategic leadership of short- and long-term goals through the use of thoughtful techniques in the communication of the company’s mission and core values as a means to implement positive change and/or create organizational structure within the assigned business unit(s)
  • Leads operational efforts through subordinates to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s)
  • Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization
  • Participates with other senior managers to establish strategic plans and objectives. Develops and coordinates simultaneous strategies/initiatives for direct departments, and contributes to the development of divisional/business unit strategies
  • Provides Physician advocacy while retaining superior relationships with colleagues
  • Responsible for directing department compliance with Medicare flagging, Sunshine Act reporting, OHRP, ICH, and GCP regulations and guidance’s
  • Works with the Compliance, Legal, HPG and Audit departments as necessary to develop or refine policies and procedures pertaining to Clinical Studies
Education Education
Bachelor’s Degree in Nursing
Bachelor’s Degree in Nursing
Columbia University
Bachelor’s Degree in Nursing
Skills Skills
  • Knowledge of applicable highly complex scientific/office procedures and techniques relating to position is desirable
  • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials
  • Knowledge in and successful application of quality improvement skills in developing and implementing quality improvement programs
  • Knowledge in and successful application of basic level of health care data analysis skills
  • Strong knowledge of Microsoft Office suite, including Word, Excel and PowerPoint
  • Detail oriented with strong analytical and problem solving skills
  • Ability to work in a cross-functional matrix organization
  • Ability to communicate and exchange information
  • Maintains current knowledge in specialty area
  • Able to manage conflicts and resolve problems effectively
Create a Resume in Minutes

15 Director, Clinical Operations resume templates

1

Assistant Director, Clinical Operations Resume Examples & Samples

  • Review and assess current operations at the Family Caregiver Support Center and identify current/future needs of the caregiving community supported by the Center
  • Direct and develop Center staff in the effective delivery and expansion of services by ensuring performance goals are created and met
  • Conceptualize, propose and implement new, innovative communication and service offerings that expand the Centers impact throughout the L.A. County area, leveraging resources at the school to maximize efforts
  • Identify and secure new funding sources that support the creation and implementation of new service delivery models and fund the expansion of existing services. Participate in strategic planning and grant writing as needed
  • Directly manage challenging cases, conduct one-on-ones, needs assessments, individual counseling services and other elements of client case management
  • Provide training, coaching and supervision to clinical staff and graduate students including weekly supervision
  • Plan, implement and manage the annual calendar of activities including fundraising initiatives, special events and outreach efforts
  • Build and expand new and existing networks, strategic alliances and partnerships by attending networking meetings, participating in industry events and representing the Center to the public and key stakeholders
  • Experience working with organizations, services, systems and leadership in the field of aging in Los Angeles
  • Experience in gerontology, work with older adults and/or caregiving preferred
  • Proficient in Microsoft Office, including Excel, MS Word and Publisher, Adobe Acrobat, In-Design. Familiarity with spreadsheets, data gathering and analysis
  • Strong interpersonal communication skills; excellent bilingual, verbal and written communication is preferred in one or more of the following Spanish, Chinese, Korean or Tagalog
  • Valid California driver’s license, good driving record and proof of auto insurance
2

Director, Clinical Operations Program Leader Resume Examples & Samples

  • Directly supervise a group of GCDO Trial Leaders, and lead the GCDO cross functional team ensuring consistencies across trials, and leveraging synergies and innovative approaches
  • Accountable for the management and development of staff while fostering a diverse work force that collaborates seamlessly in a highly matrixed environment
  • Oversee resourcing and is a key contact for the (Clinical) Project Management Lead for the duration of the program
  • You will maintain accountability and oversight of external service providers (ESP), planning and executing both internally run and outsourced trials
  • Lead CRO selection and oversight
  • A BS or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)
  • 10 or more years of clinical development experience in the pharma/ biotech and /or CRO with a proven track record of global clinical operational leadership experience (Phase 1-3B)
  • Early development (Phase I-II) / clinical pharmacology experience
  • Relevant experience in associated Therapeutic Area (Oncology)
  • Team/people leadership within a matrix environment
  • Profound experience in managing external stakeholders/CROs
  • Sound clinical financial acumen; experience managing budgets/resources
  • Able to travel up to 20% of the time, (as defined by business need)
  • Advanced degree (e.g., Masters, MBA, MD, PhD)
  • You are a trustworthy, inclusive, leader with experience in managing and mentoring global, teams, fostering team productivity and cohesiveness
  • Ability to provide strategic leadership, strong decision making, negotiating, and conflict resolution
3

Senior Director, Clinical Operations Resume Examples & Samples

  • A minimum of a Bachelor’s degree in a relevant scientific discipline is required. An Advanced Degree is preferred
  • A minimum of 12 years of relevant experience is required
  • Experience with initiating/maintaining external collaborations is required
  • Evidence of progressive management responsibilities in all phases of clinical drug development, phases 1-4 is required
  • Broad experience of effective vendor management and selection is required
  • Demonstrated ability to build, manage and retain highly functional teams is required
  • Experience in developing and implementing new processes consistent with regulatory requirement and guidelines is required
  • Excellent communication and presentation skills are required
  • The position is located in South San Francisco, CA and may require <20% travel (domestic and international).R&D
4

Director, Clinical Operations Resume Examples & Samples

  • Provides strategic leadership and oversight for GRS clinical operations
  • Determines the overall direction, strategy and performance standards for the portfolio of clinical research projects conducted within GRS
  • Accountable for the successful delivery of GRS services in the implementation of clinical trials
  • Develops collaborative alliances and relationships with clients, investigators, and advisors
  • Provides Clinical Operations expertise and leadership to cross functional project teams for assigned products and indications
  • Ensures that services provided to clients are compliant with FHI 360 SOPs and GRS procedures, ICH-GCP and country-specific regulations as well as client contractual expectations
  • Accountable for the development of Clinical Research infrastructure in GRS (e.g., SOPs, WIs, Clinical Trial Management System, budget and planning)
  • Proactively projects resource needs to ensure appropriate staffing to meet client project objectives
  • Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed client expectations
  • Manages senior staff and oversees the management of other clinical operations staff, ensuring alignment with strategic and programmatic goals and that performance meets and exceeds both business and personal objectives
  • Oversees/participates in the implementation of sponsor and investigator meetings, conferences and workshops
  • Provides key leadership and expertise in client presentations and bid defense meetings
  • Supports efforts for generating business leads (client networking, public speaking, etc.)
  • Provides leadership to proposals for project bids to incorporate therapeutic area expertise and to ensure that projects can be successfully implemented
  • Engages in strategic planning activities and implements strategic decisions into operational plans for GRS
  • Provides strategic input into the planning and selecting sites and subject recruitment strategies
  • Monitors overall portfolio, key milestones and deliverables; ensures consistent, accurate reporting to stakeholders as needed
  • Recognizes systemic issues at the portfolio level and identifies solutions with project teams or recommends actions to improve inefficiencies and oversees the implementation of best practices
  • Acts as the escalation point for any client or implementation-related issues within the portfolio; determines and executes resolution, working with FHI 360 leadership as needed
  • Provides leadership in development of new and improved processes related to trial planning, budgeting, control and management
  • Master’s Degree or its International Equivalent - Biology, Chemistry, Clinical Trials, Life Science, Sciences or Related Field
  • Typically requires 12+ years of experience in the area of clinical research, implementation, analysis, and project management
  • 5+ years’ leadership and management experience, including multi-regional and global focus
  • Must be able to read, write and speak fluent English; fluent in host country language as appropriate
  • Prior experience in a non-governmental organization (NGO), government agency, or private organization. Preferred: Relevant certifications in the area of clinical trials, and/or project management
5

Senior Director, Clinical Operations Resume Examples & Samples

  • RN or NP
  • 5 years of management in a clinical environment, health plan experience strongly preferred
  • Management experience in a matrixed environment preferred
  • 5-8 years of clinical experience, Geriatric experience preferred
  • Ability to function effectively in a senior team environment and delegate effectively to product-specific Directors of Clinical Operations and their Clinical Services Managers
  • Ability to recognize process deficiencies quickly and determine corrective measures
  • Strong presentation skills, both internally and externally
  • Ability to articulate the clinical models for our products, cultivate new business relationships, and a willingness to serve as a 'thought leader' in the medical community
6

Director, Clinical Operations Resume Examples & Samples

  • Line management responsibilities including professional development, performance appraisals, and employee counseling for junior and management staff. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level
  • Provide expert operational oversight and guidance supporting in prioritisation of activities, review and monitoring the work performed, and development of contingency plans, among others
  • Manage resource availability in the assigned country; ensuring that projects are suitably resourced and needs to hire new staff are identified in a timely fashion. Manage and control the financial performance in the assigned country, ensuring that departmental targets are met for utilization, gross profit, revenue realisation and cost control (including contractor use and staff overheads)
  • Establishes quality and performance expectations on an ongoing basis. Maintains awareness of project resourcing issues, hours and overall workloads. Provides regular updates to Regional Head of Clinical Operations accordingly. Ensures that project goals are met within appropriate timelines
  • Ensures quality and adherence to SOP /WI. Assures all staff follows mandate training and complete the required training documentation
  • Ensures that individual and work group/team tasks are completed according to country specific and government regulations
  • Works closely with Project Management, Clinical Data Management, Biostatistics & Drug Safety, Quality Assurance and Regulatory Affairs to ensure quality performance on all studies as well as to correct process deficiencies as identified by INC staff, clients, and auditors. Assist in the resolution of any project-related issues/findings associated with the performance of Clinical Operations staff in the assigned region
  • Ensures staff retention and turnover rates within the expected ranges
  • Organizes and chairs clinical staff meetings at regular intervals. Deals with issues raised or provides follow up for action items requiring resolution
  • Provides support to Business Development to facilitate the winning of new projects during the Bid Defense process, providing expert guidance where required directly or in support of a team member. May participate in marketing activities, client presentations and proposal development
7

Assoc Director Clinical Operations Resume Examples & Samples

  • Collects, tracks and reviews Clinical Operations performance metrics to assist Business Unit line management with driving consistent high quality performance and retention of CRAs
  • Assists with ongoing review and development of Clinical Operations Rewards programs globally
  • Administers the Clinical Monitoring Reward Program (CMRP) globally
  • Analyzes clinical operations performance data and indicators (e.g. scorecard metrics, PAV findings) to identify trends, issues or erroneous data, and works with the appropriate individuals to develop and implement timely
8

Director, Clinical Operations Resume Examples & Samples

  • Manage the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs). Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug supplies, etc.)
  • Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.)
  • Manage the identification, evaluation, and selection of investigators/sites
  • Ongoing assessment, evaluation and management of internal and external resources
  • Ensure study supply requirements are met
  • Ensure appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures
  • Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Valeant SOPs
  • Communicate with relevant global team members, other Valeant departments (e.g., Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilence and Drug Safety, and Clinical Supplies), and external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, and resources
  • Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees
  • Prepare study timelines and budgets and ensuring study execution is aligned with these targets
  • Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Valeant SOPs
  • Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner
  • Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc
  • Liaise with PVG and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs
  • Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner. May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process
  • Liaise with study site personnel and clinical investigators to provide study related guidance and answers to operational issues. Budgets and Forecasts
  • Provide assistance to the Head of Clinical Operations in working with Business Operations to forecast study expenditures and resourcing needs
  • With guidance from theHead of Clinical Operations, review RFPs and proposals from external vendors
  • Ensure subordinates and vendors manage and monitor study related expenses to meet forecast
  • Ensure timely communication of any variances to budget forecast to the Sr. Director or Director of Clinical Operations
  • Provide Clinical Operations support in the timely coordination and execution of clinical study reports
  • Assist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings
  • Assist to ensure annual IND and IB updates are completed in an accurate and timely manner
  • Provide Clinical Operations support to the Regulatory Affairs department. Leadership
  • Manage in-house team of Managers and CRAs for one or more studies to ensure execution of all studies in a timely and efficient manner
  • Provide leadership, training, and development support to the study team
  • May lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently
  • May serve as a representative on internal committees/teams for Clinical Operations or cross-functional activities
  • Foster a dynamic, matrixed working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging study team members to meet and/or exceed expectations
  • Encourage professional growth of personnel through regular training sessions, and by acting as a resource to clinical staff. May lead training sessions
  • Provide guidance and comments on SOPs revisions. May act as a leader of a SOP sub-committee for SOP revisions
  • May visit sites with Managers and/or Clinical Research Associates as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff. Professional Enrichment
  • Attend related courses, seminars and meetings including SOP training
  • Read professional journals and publications to stay abreast of current scientific knowledge in particular therapeutic area as well as in applicable guidelines and regulations
  • Obtain information from the field on relevant new scientific developments and identify needs for staff training, if applicable
  • Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes
  • Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management
  • Minimum 10-12 years experience in the industry with approximately 6-8 years managing clinical trials
  • 5 – 6 years experience in managing and training clinical personnel (Managers, Sr. CRAs, CRAs, project assistants)
  • Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials
  • Experience leading and working within cross-functional teams
  • Experience in managing CROs and external vendors
  • Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences
  • Ability to problem solve, build teams, and to lead and motivate others
  • Effectively work independently as well as within a team matrix
  • Financial management skills as applicable to overseeing project expenditures and forecasts
  • Advanced computer skills (Microsoft applications, spreadsheets and data displays, etc.)
  • Willing and able to travel
9

Senior Director, Clinical Operations Resume Examples & Samples

  • Responsible and accountable for one or more clinical studies with emphasis on oversight of operational activities globally
  • Leverages resources, expertise and knowledge across projects, including specific operational strategies for executing clinical studies globally
  • Oversees and coordinates budgetary activities for assigned programs including study budget creation, forecasting, accruals reporting and invoice approval. Develops and manages timelines using MS Project
  • Translates corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third party vendors and drives optimal delivery
  • Lead clinical operations strategic planning activities for clinical programs and translate strategic decisions into actionable operational plans
  • Leads the budget negotiation process and finalization with key clinical vendors. This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets
  • Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources and milestones
  • Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements
  • Leads the operational selection of various vendors and the review of proposal requests
  • Works with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing and study drug supply plans, cross-functional communication/interaction plan and monitoring
  • Manage the progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports
  • Develop and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner
  • Collaborate with the SVP-Clinical Development to generate high quality clinical study reports, investigator brochures, clinical protocols, publications and presentations of clinical study results
  • Prepare and deliver effective presentations to the Project Team, Senior Management and external parties.Provides oversight of CROs using relevant metrics and tools and monitors progress toward Clinical Operations objectives
  • Oversees contracting and budget-related activities for vendors and clinical trial sites
  • Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools etc
  • Participates in developing the feasibility and site selection strategy
  • Interpersonal Skills – Strong interpersonal and project management skills
  • Communication Skills - Excellent oral, written communication, and presentation skills utilizing all available technologies
  • Productivity/Organizing/Planning –Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously
  • Collaboration & Teamwork – Advanced competence in collaboration and teamwork
  • Relationship Management – Must be able to manage the relationship with CROs and other service providers that includes clinical study site staff, such as investigators, study coordinators, pharmacists, as well as other relevant functional team members
  • BS Degree in science or a health related field is required
  • Minimum 8-10 years relevant clinical development experience
  • Detail oriented and good problem solving ability
  • Ability to work on teams and with multiple projects, and works well under general direction
  • Excellent knowledge of GCP, ICH and FDA regulations
  • Ability to provide appropriate leadership to clinical sites and team members as appropriate
  • Independently motivated
10

Director, Clinical Operations Program Lead Resume Examples & Samples

  • Representing CDE as a key program member, responsible for the development and execution of the clinical development plans (CDPs) in conjunction with the Medical Lead
  • Bachelor’s Degree and at least 10 years global matrix drug development clinical research and operational strategy experience
  • Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning
  • Must be fully self-motivated, able to identify and take appropriate initiatives to fulfil the requirements of the role, and possess the ability to maintain a high level of productivity with minimal supervision
  • Ability to work in a highly time-sensitive environment and deliver unusually high throughput with acceptable quality when necessary
  • Expertise in Microsoft Word, PowerPoint, and Excel is required
  • Scientific education with graduate-level education in sciences or business
  • Experience in Microsoft Project and financial databases such as TrialTrove, ClearTrial, and IMS
  • Ability to perform medical literature reviews, interpreting and presenting scientific/clinical trial data; understanding statistical analyses
  • Ability to travel 15-20%
11

Director, Clinical Operations Resume Examples & Samples

  • As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
  • Provide direction and oversight to CO Managers, CO Senior Managers and CRA Management
  • Ensure all necessary training is organized and provided to assigned staff to improve their job performance and knowledge
  • Track and analyse metrics for CRA Management duties. Implement agreed corrective actions and/or further training as required
  • Provide direction to CO Managers and CO Senior Managers, and others as required, in the conduct of Monitor Assessment Visits. Conduct trending analysis and interpretation of findings and report to senior management as required
  • Undertake Monitor Assessment Visits, as required
  • Assist with designing and implementing training plans for the CRA Management team
  • Liaise with Directors, Clinical Operations, and others as needed, on issues regarding CRA performance as escalated from CRA Managers and CRA Senior Managers or Project Managers
  • Proactively identify and implement process improvement initiatives related to clinical monitoring and site management as appropriate. Obtain input from Project Managers and Directors, Clinical Operations
  • Conduct regular meetings with your reports to share information, further develop the organisation and ensure that the department is meeting its objectives
  • Participate in business development activities, as appropriate
  • Mentor, coach, and manage team performance by establishing specific goals and objectives. Share expertise
  • Conduct timely performance reviews and appraisals by acquiring feedback on the manager’s performance from Project Managers, Directors, Clinical Operations and others as required. Ensure that clear goals and objectives are set
  • Bachelor or above degree, major in science of pharmacy
  • Perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • Expert with comprehensive clinical research experience, with in depth proven line management experience in an Associate Director, CRA Management, Associate Director, Clinical Operations or equivalent job role
  • Strong working knowledge of clinical research, good business awareness and expertise in all phases of a clinical trial
  • Comprehensive knowledge and understanding of ICH-GCP
  • Demonstrated ability of highly developed problem solving skills
  • Proven experience of managing conflict effectively
12

Director, Clinical Operations Resume Examples & Samples

  • Algorithm owner to manage and maintain the application's 900+ resource planning and level of effort costing algorithms to remain current with industry standards
  • # Actively negotiating clinical CRO bids
  • Broad experience in both CRO and sponsor clinical operations
13

Director Clinical Operations Resume Examples & Samples

  • The Director will provide assistance, expertise and direction to promote the effective operation of the clinics including
  • Participate in policy making and administrative problem solving through active representation in hospital administrative meetings, departmental meetings and physician meetings
  • Provides direction to committees and teams within the department and shall participate in hospital committee functions
  • Provides and serves as a resource to the Chief of Staff, Department Chairs, and functional team chairs
  • Attends department/section meetings, as possible, to facilitate communication and encourage consensus on goals of the clinics
  • Shall serve as a liaison between the hospital and the physician’s medical practices
  • Monitors, evaluates and attends to all physician and patient complaints
  • Provides direction in order to assist staff in maintaining all equipment
  • Promotes positive physician, patient, and staff interactions
  • Provides statistical data and other reports as necessary
  • Participates in business development activities with community agencies, organizations, or groups to promote the services offered through the clinics
  • The Director will assist management in all matters related to the clinics
  • Participate in policy formulation, strategic planning, communications, and risk management
  • Assist with professional staff credentialing and formulate site builds for new location of services
  • Participate in financial planning budgeting, and long-term strategy
  • Serves as the liaison between medical staff, management and works closely with other administrative colleagues
  • Initiates, coordinates or assists in joint hospital-medical staff projects and activities
  • Promotes the mission, values and policies and procedures of the hospital
  • Ensures compliance with regulatory agencies governing the clinics
  • Assists in physician recruitment and new service development
  • Graduate of an accredited school with a Bachelor’s degree; advanced degree preferred
  • 3-year management experience in clinical hospital setting
  • Experience to include management of personnel, payroll, budgets, capital, business planning, marketing, physician relations and management of supervisory positions
  • Must have ability to interpret clinical data
  • Current Texas state license, registration or certification if required by discipline
14

Director, Clinical Operations Resume Examples & Samples

  • Operational oversight of one or more clinical development programs. Plan and initiate clinical trials including protocol development; evaluation of investigators; evaluation, selection and training of CROs including monitors; review and negotiation of study budgets; CRF design coordination; Direct the planning and execution of all operational activities involved in area of specific therapeutic indication
  • Leads cross functional teams at the program and study levels
  • Provides strategic assessment of outsourcing specifications to determine appropriate outsourcing requirements at the study, program, and corporate levels
  • Guides study team in vendor selection and management throughout the life of all assigned clinical projects. Proposes vendors to senior management for approval
  • Determines patient recruitment strategies, operational feasibility and implementation of study/program objectives
  • Ensures clinical studies/programs are executed within projected budget, on time and with quality
  • Manages and communicates to senior management overall clinical operations plan for projects including timelines, internal and external resources/costs, and key deliverables
  • Plans, convenes, runs and presents at investigator meetings and advisory boards
  • Identifies and communicates with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc
  • Manage relationship with corporate partners on studies/programs, as applicable, for clinical operations
  • Manages all aspects of a clinical trial authoring the protocol synopsis, final protocol and template informed consent form to site selection, initiation, and study start activities including drafting of study site agreements and negotiating budgets; develops and manages study specific timelines
  • Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues
  • Authors, reviews and revises Clinical Operations Standard Operating Procedures (SOPs)
  • The ideal candidate will have a BS/MS/RN or PhD in biological sciences or related field
  • Progressive experience in Clinical Operations/Research/Development with strong background in pharmaceutical, CRO and/or biotech industry
  • Minimum of 7-10 years of related experience is desired
  • Ability to interact positively with all levels of staff and liaise successfully with all levels of management in addition to being a strong team player
  • Thorough understanding of FDA, GCP and ICH guidelines
  • Strong organizational/project management/interpersonal skills
  • Strong writing and computer skills, performance oriented
  • Adept at developing and implementing metrics and clinical study patient recruitment strategies and exhibit strong presentation skills
15

Director, Clinical Operations Resume Examples & Samples

  • Executes clinical studies to establish the safety, efficacy and commercial viability of new products
  • Participates in the formulation of overall clinical strategy
  • Experience in conduction pediatric and adult hospital based clinical research trials
  • Manage Phase 1-3 clinical research and operations including strategic direction, clinical trial protocol design and initiation of clinical trials to optimize tactical and clinical value through US and Global Clinical Trial Site Selection and data portability
  • Actively participates as the lead research team member interacting with and providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures. Performs the function of Pacira’s face, thought and conscience to the investigative community
  • Manages study timelines, deadlines and budgets to include negotiating contracts with study vendors, CROs and clinical trial sites/PI’s
  • Works with clinical research/operations team and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs
  • Is responsible for site initiation, site oversight and monitoring, on-site presentations, site close-out, understanding adverse events, leads and coordinates a multidisciplinary team
  • Communicates and interacts frequently and effectively with in-house personnel, clinical sites and outside contractors/CROs
  • Participates in investigator meetings
  • Develop, revise, review and implement Pacira SOPs for Phase 1-3 Clinical trials and trial related activities
  • Ensure Pacira Pharmaceuticals compliance with all applicable regulatory standards related to US and global clinical trials and interactions with physicians. (Sunshine Act)
  • Develop and maintain professional relationships with academic and community-based physicians, clinicians and principal investigators to assure good clinical input to Pacira product development process, marketing and sales teams
  • Interface with departments within and outside of Pacira including Clinical Operations, Regulatory Affairs, Compliance, Pharmacovigilance, Commercial, Marketing, Scientific Affairs and Sales Teams
  • Provide updates and status reports to Executive/Senior Management on a regular basis to include performance against the plan
  • Masters degree in a health, biological sciences or research related field from accredited college or university required. Doctoral degree in field of study preferred
  • At least 10 years of experience in medical pharmaceutical industry with at least 3 years of hands-on managerial experience running clinical trials and managing teams required
  • At least 6 years experience managing clinical trials
  • At least 6 years experience working in the CRO matrix environment managing global development program as a Lead Clinical Research Associate (CRA)/ Clinical Trial Lead (CTL) or Clinical Program Lead (CPL) preferred
  • Demonstrated detailed knowledge of medical/surgical procedures, and hospital/acute care medical practices (pain management standards and guidelines preferable but not essential)
  • Demonstrated solid working knowledge of cGCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations including NDA, 505(b)(1), 505(b)(2) regulatory pathways, pediatric research guidelines, European Regulatory Authority Submissions etc
  • Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence,
  • Demonstrated commitment to working within Regulatory and Compliance constructs
  • Strong MS Office Skills including production of GANTT charts/timelines etc
  • Proven knowledge of and experience in Phase 1-3 clinical trial design and protocol development
  • Demonstrated understanding of statistics and statistical methods
  • Excellent analytical and organization skills; able to set priorities and meet deadlines
  • Ability to work effectively on a team in an entrepreneurial environment
  • Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems
  • Extraordinary research skills, vast experience conducting hospital based research trials and expertise in searching medical literature and databases for clinical, medical and technical information
  • Proven ability to forge cross-functional working relationships with internal teams . Clinical Trial Sites/PI’s, external contractors, vendors, and customers
  • Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the clinical trial and resolve the issues in a timely fashion
  • Ability to travel up to 70% with short notice when necessary
  • Ability to comply with all medically required hospital/clinical site immunization requirements
  • Valid driver’s license in the state in which you reside
16

Director Clinical Operations Resume Examples & Samples

  • 10 years relevant experience is required with a BS, 7 years with a MS/MPH, or 5 years with PharmD/PhD/MD
  • Experience working in both sponsor and CRO organizations strongly preferred
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant
17

Director, Clinical Operations Resume Examples & Samples

  • Responsibilities in regard to resourcing, line management, training, functional delivery and agreeing high quality measurements within the Clinical Operations group at country level. Collaboration with the Senior Director or VP on the above
  • Leading the overall delivery, through your management team, to drive execution of service, client satisfaction, quality and efficiencies
  • Overall budgeting responsibilities for your country to drive productivity and quality within the region
  • Communicate with the Senior Director and/or VP Clinical Operations, on all critical issues and business growth opportunities. To keep your Senior Director or VP informed of all critical sponsor issues and the solutions that are being worked on
  • Working closely with Business Development to support the growth of the country and provide regional/client based knowledge to achieve success. In addition to be the key contact for the country in regard to operational questions and escalations
  • Developing key relationships with the wider business both locally at country level and through the global function, in particular global project management
  • Working closely with the functional heads of CRA monitoring and Study start up activities so that global consistency, focus and development are achieved across their remit
  • Drive innovation and continuous improvement in all areas of responsibility
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
18

Senior Director Clinical Operations Resume Examples & Samples

  • Audit the results of clinical initiatives and provide senior leadership and customers reports of progress
  • Partner with corporate departments to evaluate divisional performance and determine appropriate training and support to positively impact outcomes
  • Participate in the development of strategic direction for clinical services to ensure the development of supporting outcome programs
  • Accountability and responsibility for corporate clinical outcomes reporting and working in partnership with VP’s and center teams for specific center process improvement
  • Monitor and report on Clinical investigation processes within assigned division
  • Assist in the development and identify issues that require the establishment, review, and/or modification of clinical Policies and Procedures and/or educational materials
  • Benchmark centers’ outcomes; identify and share best practices
  • Assist in providing technical, data, and statistical support for provider profiling, quality improvement projects, clinical service activities, JCAHO reporting, and key indicator monitoring to DVP, ROD, ACM, and VP of Clinical Operations
  • Ensure quality management programs are in place and functional in the facilities
  • Support Interventionist and clinical team as necessary to deliver high-quality vascular care and outcomes
  • Ensure compliance with all state and federal laws and regulations including but not limited to radiology, safety/OSHA, JCAHO
  • Coordinate with VACOps and Marketing detailed analysis of patient and provider surveys along with activities to improve
  • Advanced degree in Organizational Development, Nursing (and current licensure), Healthcare Management or related field or equivalent experience with Bachelor’s degree in related discipline
  • National Certification in related field of experience (ie, CNN, CHDN, CPME)
  • Minimum of ten (10) years’ experience required including proven results working within a quality improvement environment (ie. Six Sigma, CQI, etc.)
  • Solid reasoning, critical thinking, and problem solving abilities
  • Ability to evaluate outcomes and determine appropriate training and support to positively impact outcomes
  • Strong communication, presentation, and interpersonal skills
  • Intermediate computer skills and proficiency in MS Word, Excel and PowerPoint with ability to create presentations and use the Internet effectively
19

Senior Director, Clinical Operations Resume Examples & Samples

  • Bachelor’s Degree and an active RN license
  • 5+ years leadership and management experience
  • Minimum of 8 years clinical management experience to include 2 years of geriatric experience
  • Strong negotiations skills, budget management experience and regulatory knowledge
  • Ability to work across functions and businesses to achieve business goals
  • Effective in motivating and mentoring colleagues and peers
  • Master’s Degree preferred, ideally in nursing or business
  • Nurse Practitioner strongly preferred
20

Director, Clinical Operations Resume Examples & Samples

  • Contribute to strategic planning to ensure optimized clinical development plans for assigned projects in alignment with company goals
  • Ensure operational feasibility of clinical development plans and scenarios, including development of, and management to, timeline, budget and resource requirements. Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and AnaptysBio SOPs
  • Drive clinical research activity including resourcing, staffing, and direction and action plans with investigational sites, CRAs, and CROs
  • Develop, implement and maintain standards across clinical studies within a program including but not limited to new hire training for CTMs/CRCs, tools, templates and CRO manuals
  • Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
  • Provide assessment of outsourcing requisites and options to determine appropriate outsourcing selection at the study, program, and corporate levels
  • Guide study team in vendor selection; managing vendors throughout the life of all assigned clinical projects. Propose vendors to senior management for approval
  • Coordinate the preparation and finalization of IND submissions, investigator brochure updates, DSURs, NDA submissions (and/or country-specific equivalents)
  • Provide technical expertise for the development of clinical documents, including prioritizing, authoring, and approving study activities (i.e. protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
  • Develop the infrastructure to support advanced clinical trials
  • Coordinate closely with all internal stakeholders to ensure operational excellence
  • Identify and communicate with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc
  • BA/BS in related scientific or healthcare field and 15+ years of progressive clinical operations experience in the pharmaceutical or biotechnology environment, with a preference for antibody/biologics experience
  • Proven track record of planning, managing and conducting clinical operations for Phase 1-3 studies, including operations and strategic planning thereof, and submissions of investigational new drug through new drug application filings
  • Experience managing the clinical operations across multiple therapeutic areas is a plus
  • Experience in a hands-on early development role within a small organization is a plus
  • Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors
  • Track record of leading a cross-functional team in a matrix environment
  • Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize
  • International experience is highly preferred
  • Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, ICH, and GCP requirements (and/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs
  • Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
  • Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance
  • Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm and commitment, and to gain approval/sponsorship for projects. Listens and seeks clarification; responds effectively to inquiries or complaints
  • Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well
  • Excellent organizational and problem solving skills with the capacity to organize assignments and work within deadlines
  • Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
  • Position may require occasional evening and/or weekend commitment
  • Position may require occasional domestic and international travel
21

Director Clinical Operations Resume Examples & Samples

  • Supervises integration of ICC Intensivist Program by aligning the Intensivists and ICC Intensivist program policies with the ICU nursing staff – through in servicing of ICC protocols, facilitating communication amongst ICU team members and emphasizing compliance with key clinical initiatives. 
  • Director of Clinical Operations to work together with ICC Regional Director of Medical Operations providing analytical and logistical support, regular program site visits in designated geographic region, Clinical assessment and ensuring consistency of ICC Intensivist Program Model. 
  • Director of Clinical Operations will provide direct oversight and supervision in addressing clinical corrective action plans and provide regular updates to the ICC and facility administration. 
  • In services ICU Nursing Director to the ICC program roll-out and implementation and TEAM building strategies. 
  • Facilitates streamlining of documentation efforts, Meditech integration and utilization of ICC order sets. 
  • Facilitated PQRS compliance and physician Healthstream course compliance.
  • Participates in critical care, vent optimization and sepsis committees – reviewing Clinical Excellence Dashboard exploring and suggesting strategies to achieve best clinical practice in alignment with ICC and HCA programs.  Supervises new ICC Program implementation and integration – providing gap analysis and feedback. 
  • Provides Clinical Documentation Peer review – improving DRG coding accuracy and capturing accurate charges. 
  • Provides oversight in patient hand-off, sign out process ensuring continuity of care and meaningful transition of care model. 
  • Identifies variation in practice and explore streamlining of care model and protocol utilization. 
22

Director Clinical Operations for Acute Medicine Services Resume Examples & Samples

  • Assumes responsibility and accountability for the development, coordination and evaluation of clinical programs of nursing care, nursing practice standards, evidence-based education and competencies within The Department of Nursing and the AMSL
  • Responsible for providing timely written and verbal communications to the Vice President of Patient Care Services that enables swift attention to time sensitive business matters
  • Ensures compliance with all applicable policies and procedures and routinely reviews and revises policies in accordance with CCHS standards
  • Ensures interpretation and understanding of legal/regulatory requirements and is responsible for compliance and ongoing readiness through a comprehensive monitoring, evaluation, and communication plan
  • Develops, maintains, and manages relationships to maximize the impact of quality and satisfaction initiatives including developing strong relationships with medical staff, the leadership team, and the nurse leaders and staff of the patient care units. This includes collaborating and partnering with the Unit Based Medical Directors within the AMSL. Provides ongoing communication and disseminates AMSL updates to stakeholders across the health system
  • Participates in and promotes the shared governance model of the Department of Nursing
  • Contributes to the strategic planning process for the AMSL, including developing and implementing short and long term strategic plans for the AMSL
  • Responsible and accountable for monitoring and evaluating AOP and AMSL goal attainment. Communicates barriers to goal attainment to the appropriate leaders and the Vice President of Patient Care Services
  • Manages the fiscal and budgetary demands placed on the AMSL by addressing staffing, workforce planning, procedure location, patient flow, patient access and all other issues that impact the ability of the AMSL to perform in a fiscally responsible manner
  • Coordinate and facilitate patient flow throughout the medical nursing units in collaboration with Emergency Department, Director of Clinical Operations/ Patient Placement, and Nursing Coordinators
  • Registered Nurse. Current licensure in the State of Delaware
  • Master’s Degree required
  • Professional certification required. Nurse Leader certification preferred
  • Minimum of five (5) years recent and progressive managerial experience in a clinical setting. (prefer Critical Care or Step-down experience)
23

Assistant Director Clinical Operations Resume Examples & Samples

  • Collects, interprets, and documents specifications required to develop new and revise existing programs. Develops and implements operational plans for new and existing programs. Participates in development of project proposals for customers. Develops and/or oversees development of budget for program
  • Makes formal presentations to various senior level audiences. Serves on committees as representative of assigned program as appropriate
  • Compiles complete, concise and comprehensive policies and operation procedures to assist in communicating issues to applicable management staff. Recommends new policies and procedures for improvement of program activities
  • Interpret, explain, and discuss data analysis results with project teams. Makes recommendations and support strategies for improving clinical processes and patient outcomes including management of patient responsiveness, call triage, documentation of care, wait times, and care management
  • Oversees the optimization of space utilization and ongoing facility development/maintenance. Directs the asset acquisition review process and facilitates requests to accommodate incremental space needs in partnership with the Medical Director and Department Chairmen. Maintains and executes business continuity plans as needed
  • Directs marketing and community integration plans. Works closely with the Outreach department to build relationships with community providers and increase awareness of services provided. Closely monitors referral patterns and works with providers to build practice volumes to desired panel sizes
24

Hospice Regional Director Clinical Operations Resume Examples & Samples

  • Bachelor’s degree in nursing preferred
  • Registered Nurse licensure
  • Expressed interest in details of documentation and quality
25

Director, Clinical Operations Resume Examples & Samples

  • Owns and maintains a strategic working relationship with hospital leadership; communicating frequently regarding process outcomes and opportunities for growth
  • Proactively keeps IMS leadership apprised of potential challenges or opportunities
  • Ensures IMS staff and leaders maintain a healthy working relationship with the hospital staff
  • Utilizes lean principles and continuous improvement to drive process improvement and operational efficiency with the assigned Customer
  • Monitors quality metrics and productivity on a monthly and quarterly basis
  • Prepares IMS metrics reviews in quarterly business reviews and presents to hospital leadership
  • Participates in the development and implements of annual plans to ensure current contract compliance
  • Facilitates the financial improvement performance initiatives as related to contracted facility
  • Oversees key projects such as process improvements or capital investment projects
  • Provides leadership for employee relations through effective communication, coaching, and development
  • Partners with peer group to advance site specific and cross-company growth
  • A Bachelor’s degree from an accredited university or college required; Master’s degree from same preferred. Individual must possess a minimum of 8 years combined leadership experience including three to five years in a management position with direct reports
  • Must be proficient in project management and strategic thinking
  • Effective negotiating and influencing skills
  • Strong analytical skills with advanced knowledge of Microsoft Office applications. Must be capable of learning additional software as required
  • Excellent multi-tasking, priority setting capabilities
  • Must possess solid managerial, analytical, organizational skills and financial acumen
  • Must have solid understanding and leadership experience in Lean Manufacturing
  • Proven ability to recruit, train, and motivate personnel in order to balance staffing strength with profitability and growth
26

Director Clinical Operations Resume Examples & Samples

  • 5 years current progressive management experience in a healthcare setting; clinical experience managing a variety of disciplines
  • 5 years of management experience,
  • Registered Nurse with current health care management
  • Theory and practices; effective communication and problem-solving
  • Techniques; standards from regulatory agencies and accrediting organizations
  • Financial management and healthcare
  • Economics; Strategic planning and
  • Performance improvement; project
27

Director Clinical Operations WAG Phys Admin Days Resume Examples & Samples

  • 5+ years’ experience in clinical setting, with experience in management
  • Master’s Degree in Nursing, Healthcare Administration, Finance, or other Health-related field
  • 2+ years’ experience planning, developing, and managing departmental expense and capital budgets
  • 2+ years’ experience directly managing people, including hiring, developing, motivating, and directing people as they work
28

Director, Clinical Operations Resume Examples & Samples

  • A minimum of a Bachelor's degree is required
  • An advanced degree (i.e. Master's, PhD, etc.) is preferred
  • A minimum of 10 years of clinical research and/or project management experience within the pharmaceutical industry is required
  • Previous leadership experience in overseeing clinical research and outcomes research programs is required
  • Immunology therapeutic area experience is preferred
  • Experience developing strategy as well as business goals and objectives across a portfolio is preferred
  • Experience managing finances (both clinical and administrative) for a trial/program and across a portfolio is required
  • Strong leadership, interpersonal, and communication skills are required
  • Ability to operate in a matrix environment and experience working with cross-functional alliances is required
  • Considered by peers as a clinical trials and drug development expert, technically proficient, intelligent, and results oriented
  • Must be a high-performing individual with ability to think creatively, critically, and proactively, with strong problem solving skills
  • Must be able to prioritize, work independently, and have ability to be flexible and manage multiple priorities
  • Experience in real-world evidence trial management is preferred
  • This position will be located in Horsham, PA and will require up to 10% domestic and international travel4380170309
29

Director, Clinical Operations, Onkaido Resume Examples & Samples

  • Study Management of first-in-patient clinical trials of Onkaido development candidates
  • Manage assigned clinical trial budgets
  • Develop and maintain strong, collaborative relationships with key stakeholders within Onkaido and Moderna
  • At least five years of global trial management experience in a clinical research environment, most of which should be in industry and in Oncology
  • Solid experience in oncology and/or hematology indications
  • Cross Collaboration proficiency with other functions such as Research, Drug Supply, and Finance
  • Outstanding verbal and written communication skills including clinical authoring experience including protocols and investigator brochures
  • Excellent organizational skills and ability to work independently
  • Creative, capable problem-solver
30

Director Clinical Operations Cancer Institute Resume Examples & Samples

  • Bachelor’s Degree in health care, business, economics, or related field
  • 7-10 years of management or administrative experience in health care, preferably in an integrated health system with an in depth knowledge of healthcare clinical operations, revenue cycle management and finance
  • Working knowledge of healthcare reimbursement principles, health care reform, new healthcare reimbursement and financing models, information systems, cost management, quality management, culture of excellence and change management
  • Understanding and familiarity of data implications of EPIC EMR (or similarly complex EMR)
  • Strong understanding of clinical operations revenue cycle management and optimization
  • Solid business and financial acumen
  • Strong leadership and organizational skills, including prioritizing work and managing time effectively, mentoring others and motivating team to accomplish goals and objectives
  • Specific experience in directing cancer clinical operations
31

Senior Director, Clinical Operations Resume Examples & Samples

  • Line management responsibilities including professional development, performance appraisals, and employee
  • Provide expert operational oversight and guidance supporting in prioritization of departmental activities,
  • Ensures that individual and work group/team tasks are completed according to country specific and
  • Organizes and chairs clinical staff meetings at regular intervals. Deals with issues raised or provides follow
32

Director, Clinical Operations Resume Examples & Samples

  • Study Management of first-in-human and early phase clinical trials of development candidates
  • Manage cross functional leadership and CRO/vendor management related to clinical trial operations aspects
  • Lead in the selection and oversight of CROs and other vendors
  • Develop and lead the review of clinical outsourcing strategies and plans
  • Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
  • Along with other Clinical Development personnel, represent the Company externally to Investigators and trial site administrators
  • Maintain oversight and participate in the review of departmental SOPs to ensure compliance
  • Develop and maintain strong, collaborative relationships with key stakeholders within Moderna
  • At least five years of global trial management experience in a clinical research environment, most of which should be in industry and with global trials
  • Advanced degree preferred or Bachelor’s in a science-based subject
  • Cross therapeutic experience including infectious disease or vaccine trials
  • Solid experience in early phase drug development and proven track record of success
  • Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
  • Experience in regulatory GCP inspections/audits
  • Proven track record of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
  • Experience in establishing and maintaining relationships with key opinion leaders
33

Director, Clinical Operations Resume Examples & Samples

  • Allocate Clinical Manager (CM) resources to adequately address Client/HP service needs and to accommodate fluctuations in territory size and team member schedules
  • Develop and maintain relationships with Client contacts in order to maximize service excellence and improve issue resolution
  • Deliver business presentations or other formal communications to Clients and/or internal business partners
  • Facilitate CM problem solving on critical escalations by providing insight and guidance above the Policy and Procedure guidelines
  • Perform and interpret internal audits of CM work to recognize and plan for opportunities to improve
  • Conduct regularly scheduled 1:1 meetings with team members to assess work performance, inform, plan and to motivate and inspire; address and coach performance issues with team members
  • Facilitate Individual Development Plan (IDP) process with direct reports in order to support personal, professional and business growth
  • Takes a leadership role in approving exceptions to standard guidelines for core functions (application review, reference review, conviction and license disciplinary review)
  • Provide direct/ primary support to Clients/Clinicians in travel nurse, allied, pharmacy and local staffing by performing all duties of a Clinical Manager for a modified client territory
  • Acts as Subject Matter Expert for Clinical Operations process, managing medium to large scale projects and developing and delivering training
  • 5 years as RN in acute care setting
  • 2 years of direct supervisory or managerial responsibility
34

Director Clinical Operations Resume Examples & Samples

  • Assists in the development of the Strategic Plan for Nursing/Patient Care Services that is aligned with the organizational vision. Translates the plan into goals and objectives for own team, sets priorities and directs the efforts of staff toward accomplishing those goals and objectives
  • Analyzes market strengths/weaknesses of current program and identifies opportunities for business development and growth, service improvements and improved financial performance. Integrates key physician leaders into planning and management of patient care services. Creates and implements plans to increase patient volume through assuring physician satisfaction with clinical operations
  • Assists in developing the divisional operating and capital budget, and ensures that the division operates within the budget. Develops strategies to achieve goals for cost management and develops financial indicators to monitor progress for review and analysis of financial performance
  • Ensures the development of the standards of performance, evaluation of performance, and initiates or makes recommendation for personnel action. Holds self and team responsible for maintaining the highest possible performance standards and meeting agreed upon commitments even under difficult circumstances
35

Director, Clinical Operations Resume Examples & Samples

  • Oversee all aspects of clinical operations within the PAREXEL Early Phase unit
  • Possesses thorough knowledge of all current Early Phase study protocols and design
  • Organizes the Clin-Ops meetings (which hands studies over from Business Development/Business Administration to Clinical Operations)
  • Performs and assists in client pre-site, site and audit assessments for the Early Phase Units
  • Provides Early Phase feasibility for study protocols and design with the clients
  • Provides support to Business Administration and Business Development as appropriate
  • Manages all activities and staffing issues, including hiring, training, scheduling, coaching/counseling, evaluating performance and terminating staff. Able to review and approve all timesheets
  • Meets regularly with Managers/Directors to discuss staffing for upcoming studies, sharing of staff between departments, and overtime reports. In conjunction with the Unit Head and Senior Management, authorizes all hiring, transfers, performance reviews, increases, and terminations in the Early Phase, pharmacy, nursing and the laboratory depts
  • Organizes the Managers and Supervisor operational meetings, meets regularly with the Unit Head
  • Provides clinical input on protocols in development. Identifies which protocols can or cannot be done feasibly/profitably
  • Establishes and maintains relationships with clients, vendors, and hospital representatives
  • Reviews, tracks and approves all Departmental expenses
  • Works closely with Enrollment on recruitment strategy/issues
  • Reviews draft consents; offers suggestions to Project Management
  • Works closely with Project Management in drafting regulatory timelines for studies
  • Manages all aspects of departmental performance improvement strategies including: identifying areas for improvement, developing an action plan in conjunction with all affected areas/staff, and tracking and reporting results to Sr. Management
  • Determines the necessity for the creation of departmental Standard Operating Procedures (SOPs) in adherence to regulatory requirements. Oversees and approves the review, revision, and/or retirement of departmental SOPs. Upon approval, oversees the training and implementation of departmental SOPs and inter-departmental SOPs
  • Maintains and updates knowledge of Good Clinical Practices (GCPs) and their proper application. Reinforces the use of GCPs departmentally through example and staff training
  • Ideal candidate will have management experience
  • Computer proficiency required
  • Meticulous attention to detail
  • This position requires strong interpersonal, written/verbal communication and organizational skills
  • Must have the ability to effectively manage time, manage resources and multi-task
  • Experience in a clinical research environment, with knowledge of the clinical operations of an investigative site preferred
36

Director, Clinical Operations, Vaccines Resume Examples & Samples

  • Leadership of first-in-human and phase 2 vaccine clinical trials ensuring GCP and FDA Regulatory compliance
  • Work with the internal project team and manage the preferred provider CRO team and vendors to plan and implement clinical trials for a number of new vaccines
  • Manage assigned vaccine clinical trial budgets and resource assignment
  • Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with global operational standards and procedures
  • Initiate and lead monitoring oversight activities are conducted in accordance to Moderna and ICH/GCP standards
  • Represent the Company externally to Investigators and trial site administrators
  • Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
  • Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization
  • At least 8-10 years of management experience in an infectious disease vaccines clinical research environment
  • Cross Collaboration proficiency with other functions such as R&D, Finance and production
  • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
37

Senior Director, Clinical Operations CNS Resume Examples & Samples

  • Collaborates with Regional Heads of Development Operations to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of clinical trials in support of IGDP and studies in assigned TA or TAs
  • Direct management of Clinical Program Managers and Associate Directors, Study Management (who manage clinical study managers)
  • Provides central point of contact for global clinical operations to PDD Therapeutic Area Heads, Strategic Project Management, Therapeutic Areas Leads, CMSO Global Project Leaders and Finance for strategy, planning, issue management, and program execution information
  • Responsible for global budget planning/forecasting and management for assigned therapeutic area or disease pathway
  • Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues. Represents Development Operations (including Global Development Strategic Outsourcing) in senior PDD management forums
  • Supports Global Development Strategic Outsourcing by leading portfolio level planning and Early Engagement process with strategic vendors in assigned therapeutic area or therapeutic areas, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of performance issues
  • Leads and/or Participates in Global Clinical Operations, Development Operations or TDC initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives
  • Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable
  • At least 12 years clinical study/program management experience in the pharmaceutical industry, including at least 6 years of line management experience. Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level required
  • Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes)
38

Regional Director, Clinical Operations Resume Examples & Samples

  • Monitors quality metrics and productivity on a daily basis
  • Develops and implements annual plans to ensure current contract compliance
  • Oversees the development and growth of mid-level management including, but not limited to Outsource Clinical Operations Managers and OR Process Improvement Liaisons
  • Communicates frequently with senior hospital leadership within contracted facilities regarding process outcomes and opportunities for growth
  • Facilitates the financial improvement performance initiatives as related to contracted outsource account facilities
  • Coordinates with internal directors to advance site specific and cross-company growth
  • Promotes safe and healthy work environment and culture in all engagements by following and enforcing safety and health policies and complying with codes and legal regulations
  • Supports Human Resources initiatives such as Employee Engagement Surveys, Annual Performance Evaluations/Merit Increases, development of annual MBOs, Talent Management, as needed
39

Senior Director, Clinical Operations Resume Examples & Samples

  • Provides strategic leadership of short- and long-term goals through the use of thoughtful techniques in the communication of the company’s mission and core values as a means to implement positive change and/or create organizational structure within the assigned business unit(s)
  • Leads operational efforts through subordinates to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s)
  • Directs and controls the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and processes appropriate to the functional area(s)
  • Ensures budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods
  • Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance
  • Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization
  • Strategic leader with broad-based knowledge in individual departments, and strong knowledge of industry practice and business principles. Works on complex issues and abstract issues/situations where analysis of situations or data requires an in-depth knowledge of the company
  • Participates with other senior managers to establish strategic plans and objectives. Develops and coordinates simultaneous strategies/initiatives for direct departments, and contributes to the development of divisional/business unit strategies
  • Interprets and provides recommendations for change of company-wide policies and practices. Establishes policies appropriate for the function
  • Provides Physician advocacy while retaining superior relationships with colleagues
  • Accountable for assisting with achieving the CSG’s strategic direction and will be expected to focus on value and financial stability
  • Responsible for directing department compliance with Medicare flagging, Sunshine Act reporting, OHRP, ICH, and GCP regulations and guidance’s
  • Works with the Compliance, Legal, HPG and Audit departments as necessary to develop or refine policies and procedures pertaining to Clinical Studies
  • Coordinates and supervises multiple ongoing studies (pharmaceutical and device) at multiple locations according to established policies and procedures
  • Provides leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce
  • 10+ years’ related experience
  • 5+ years’ experience as a Director; or 5+ years’ experience in a senior managerial role
  • Strong management skills with the ability to lead cohesive and productive teams
  • Ability to influence
  • Strong knowledge of FMC field organizational structure required
  • Ability to work independently and be detail oriented
  • Must be able to meet time deadlines for multiple concurrent projects
40

Director, Clinical Operations Resume Examples & Samples

  • Manages clinical operations across multiple offices in multiple states
  • Provides oversight and controls operational and performance metrics in conjunction with established division targets
  • Develops and enhances solutions to address new, often complex customer requirements that address operational, clinical and customer needs
  • Develops standardized benchmarks and “best practices” across all sites
  • Provides input into forecasting and planning activities
  • Develops and maintains standardized outcomes and productivity reporting
  • Develops and maintains standardized policies and procedures
  • Develops internal review guidelines, operational review processes and procedures to ensure contract deliverables while maintaining high quality and performance standards across all contracts
  • Develops presentations and other documents related to clinical operations for customers or other internal customers
  • In coordination with the Quality Management Department, develops and maintains quality standards
  • Performs other functions as assigned
  • Outstanding interpersonal skills with customer service orientation
  • Strong knowledge of Microsoft Office suite, including Word, Excel and PowerPoint
  • Ability to work in a cross-functional matrix organization
  • Greenbelt certification preferred
  • 8+ years’ healthcare leadership experience
41

Director, Clinical Operations Resume Examples & Samples

  • Provides oversight for company's coordination of clinical initiatives and communication of the same to its stakeholders
  • Assists the CMO, the BIDCO medical directors and the Senior Leadership Team with clinical strategic planning, budget development and resource management
  • In collaboration with the CMO and CIO, directs the company's Population Health Management system
  • Directs the platform and content of the company's clinical web presence
  • Develops and administers clinical policies and procedures with internal staff and external customers designed to ensure efficient business processes, communications and operations
  • Has the authority to direct and support managers with functional area responsibilities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: 2-3 Indirect Reports: None
  • Bachelor's degree required. Master's degree in Health Administration preferred
  • 5-8 years related work experience required in health care field and 1-3 years supervisory/management experience required
  • 3-5 years of experience in operations required
  • Must be able to work effectively in team-focused environment and communicate well with physicians and executive leadership on complex subject matters
  • Must be able to travel
  • Experience managing large scale projects
  • Oral Communications:Ability to verbally communicate complex concepts in English and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others
42

District Director Clinical Operations Resume Examples & Samples

  • Conducts on-site reviews of clinical operations, medical records and staff performance
  • Reviews facility clinical activities and initiates corrective action/programs as needed
  • Educates facility personnel in clinical and regulatory issues and Kindred policies
  • Provides guidance and assistance to Directors of Nursing Services
  • Establishes and maintains a peer networking system for DNSs
  • Identifies quality of care issues and takes appropriate action
  • Skilled in directing and motivating the workforce
  • Skilled in analytical evaluation
43

Director, Clinical Operations Resume Examples & Samples

  • Works collaboratively to identify potential new regional study coordinator sites and works to establish new locations including lease negotiations and agreement execution
  • Manages operations at research sites with DCR employed study coordinators
  • Facilitates timely issue escalation and resolution for physicians and study sponsors as related to field operations
  • Manages physician relationships as related to clinical research
  • Works with physicians to promote appropriate principle investigator oversight
  • Works with physicians to identify appropriate sub-investigators and succession plans
  • Maintains relationships with healthcare operations leadership: Regional Operations Directors and Facility Administrators as related to research operations
  • Oversees local site training and clinical study execution to ensure the delivery of projected enrollment targets
  • Understands and promotes compliance with all applicable healthcare and research regulations
  • Coordinates with Quality Assurance to ensure teammates are trained on Standard Operating Procedures, research regulations and applicable healthcare regulations
  • Conducts quarterly operations reviews with local physician research groups
  • Assists the Director of Operations in preparing monthly operational updates for senior leadership
  • Participates in strategic planning to develop and grow business operations
  • Provides direct supervision and work direction for department teammates
  • Determine staffing plans that promote the most effective use of all teammates; ensure coverage during teammate absences
  • Assist in the development and maintenance of teammate training, reference and audit tools
  • Knows, understands, implements, follows, and communicates to teammates all DaVita employment policies and procedures, awards, and other opportunities within company and foster a positive work environment
  • Facilitates teammate development (PDRs, coaching, mentoring, DaVita training, outside training); collaborates with direct reports to create professional development goals
  • Maintains familiarity with and communicates to teammates DaVita programs impacting teammates
  • Addresses teammate relations issues appropriately and escalate as necessary
  • Minimum BS/BA prefer science area of study
  • Minimum 5 years of Clinical Research Experience or equivalent experience
  • Minimum 5 years of direct management experience
  • Travel required, less than 50%
  • Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through
  • Innovative, analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives
  • Demonstrated ability to create, refine, and manage new business processes
  • Deals with confidential information and/or issues using discretion and judgment
  • Commitment to and role model of DaVita’s values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions
44

Director, Clinical Operations Resume Examples & Samples

  • Bachelor or Master's Degree in a health-related field
  • Eight (8) years related experience in life sciences, including clinical development experience
  • Proven track record as a leader in clinical trials in the biotech or pharmaceutical industry
  • Experience and knowledge of ICH-GCP and other relevant regulations
  • Strong interpersonal, written/ verbal communication and organizational skills
  • Ability to effectively manage time, resources and multi-task
45

Director, Clinical Operations Resume Examples & Samples

  • Bachelor's degree in a health care or other scientific discipline
  • 8 yrs of experience working on clinical trials
  • 5 years experience in a leadership capacity
  • In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Strong customer management experience
46

Director, Clinical Operations Resume Examples & Samples

  • Develops and executes clinical operation plans to meet ClinicalRM’s short and long term government and commercial growth goals
  • Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
  • Responsible for the development and deployment of enterprise project controls tools, methodologies, and systems
  • Manages protocols, amendments, CRFs, informed consent form, operations and other documentation required for conduct of a clinical trial
  • Maintains and manages internal clinical trial files and documents
  • Manages the preparation of required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols
  • Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities
  • Responsible for the development of effective PMO program/project tools to aid in process standardization (project audits, reports, templates, knowledge management tools such as a “Lessons Learned” library, and intranet)
  • Maintains a master status list of all projects and provides "dashboard" reports and analysis to senior leadership
  • Ensures the overall quality of project services and deliverables by scheduling and conducting regular project and program reviews
  • Proactively tracks and manages leading performance indicators to ensure the high-quality, timely, and cost effective execution of ClinicalRM contracts and clinical trials
  • Ensures compliance with all applicable government, corporate, and client policies, regulations, and standards
  • Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
  • Cultivates a strong and transparent working relationship with the Executive Team and ensure open communication about the measurement of financial, programmatic, and impact performance against stated milestones and goals
  • Perform light duties and other related duties as required and assigned
  • Bachelor’s degree in science or related field. Advanced degree preferred
  • 5+ years’ experience in clinical research, with experience or understanding related to Infectious Disease preferred
  • 2+ years’ experience in project or program management. PgMP® or equivalent certification preferred; if not certified, must be able to obtain certification within 6 months of hire. Demonstrated experience in Program Performance, Business Development, Leadership, Negotiations, Risk Management, and Decision Making
  • Demonstrated ability to recognize overall strategic and tactical objectives of the company and customer programs
  • Ability to identify issues, track progress, and follow through on actions to meet customer satisfaction
  • Skilled in communicating issues, impacts, and corrective actions to varying levels of corporate personnel and customer leadership personnel
  • Excellent written, verbal, and interpersonal communication skills, organizational skills and a great attention to detail are required. This individual must be able to work as a member of a team and possess good problem solving skills
  • Possesses the ability to organize, instruct and supervise staff, while promoting group effort and achievement
  • Able to manage conflicts and resolve problems effectively
  • Experience with MS Office including Access, Word, PowerPoint, Project and Excel
  • Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification strongly preferred. Within 90 days of hire, must successfully complete certification in Human Subjects Research
  • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials
  • Maintains current knowledge in specialty area
  • Knowledge of applicable highly complex scientific/office procedures and techniques relating to position is desirable
  • Must be able and willing to travel up to 25%
47

Director Clinical Operations Resume Examples & Samples

  • To be accountable for the planning and delivery of clinical trial milestones according to the overall clinical development plans across the R&D portfolio
  • To lead a team of Clinical Project Managers and Directors; to coach team members to optimally perform in managing individual clinical programs and individual studies
  • To forecast and track internal and external resources needed to deliver clinical studies as per agreed development plans
  • To ensure that the conduct, completion, recording and reporting of assigned clinical trials are carried out according to relevant GCP standards and regulatory/legal requirements
  • To identify risks in meeting study milestones and to address resolutions of the issues with project or study teams as required
  • To liaise with related functions/departments, e.g. Biometrics, Clinical Study Supplies, Imaging Technology, Regulatory Affairs; Medical Affairs, Portfolio/Program Management, Quality Assurance; Pharmacovigilance; Finance; Contracts; Legal and Compliance
  • To collaborate with key stakeholders involved in CRO management and participate to selection of external providers of clinical services
  • Scientific degree in Natural/Life Science or equivalent
  • Strong Pharmaceutical, Biotech, CRO or Medical Device industry experience
  • Experience in GCP Clinical trials, preferably as a Clinical Project Manager
  • Work related experience in Clinical Research, ideally within the field of cardiology
  • Experience in working with outsourcing of clinical trials to CROs
  • Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
  • Previous line management experience in clinical operations
  • Excellent interpersonal, organization, communication, & influencing skills, able to work with internal and external stakeholders
  • Previous experience in clinical development of imaging agents
  • Ability to work independently and with rigor
  • Prior experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook) and MS Project and/or other project management software
48

Senior Director, Clinical Operations Resume Examples & Samples

  • Align with the Head of Clinical Development Operations on plans for successful implementation of CE clinical programs (DS sponsored clinical studies , Investigator initiated studies, expanded access programs)
  • Provide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP
  • Accountable for the management of all compounds within CE
  • Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departments with the goal of delivering high quality data in support of regulatory filings
  • Accountable for consistent and successful execution of all operational aspects of regional and global studies within CE with speed , quality and cost in mind
  • Establish and monitor key performance indicators to ensure delivery of the CE portfolio is consistent with the yearly objectives
  • Influence project/clinical subteams to ensure operational aspects are incorporated into Clinical Development Plans and individual protocols to facilitate successful implementation of programs; ensure proactive risk assessment of each protocol to determine the optimal execution strategy
  • Accountable for the effective support of clinical activities within the Development organization
  • Engage and motivate CO employees to execute the strategy through collaboration and transparent communication
  • Member of the CO leadership team and global clinical operations committee enabling cross functional and regional collaboration, delivery of regional and global objectives and implementation of process improvements
  • Single point of accountability representing CO on the CE Strategy and Portfolio team
  • Establish resourcing model to support the CE portfolio and manage resources efficiently
  • Contribute to the development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements
  • Lead the operational design and implementation of external collaboration outsourcing models (e.g. program level outsourcing) in collaboration with Outsourcing Procurement Management, legal and relevant functions
  • Represent CO on DS/Academic research Organization/CRO governance structures (e.g. Joint operations committees, steering committees)
  • Lead the integration efforts to ensure optimized vendor management and oversight at study level
  • May be asked to represent CO at senior management meetings on behalf of the Head of Clinical Development Operations
  • Provide leadership to CO staff and to project teams for Vendor evaluation, selection , management and oversight
  • Provide guidance and training to CO members of clinical study teams to ensure quality delivery of clinical trials on time and on budget
  • Provide leadership and guidance to clinical operations members of clinical study teams to accelerate execution of clinical studies , as applicable
  • Develop best practices and lessons learned mechanisms within CO
  • Develop risk assessment & risk management and clinical project management competencies within CO
  • Work in collaboration with PERM and Quality Assurance to develop and implement quality activities within CO
  • Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study planning and execution, in collaboration with relevant functions
  • Ensure TMFs for CE trials are kept in an inspection ready state
  • Assist in developing and overseeing the implementation of CAPA in relation to sponsor’s audit or regulatory inspections
  • Support the Head of Clinical Development Operations in establishing and maintaining an organizational structure and staffing to effectively accomplish the CO goals and objectives
  • Responsible for the management and leadership of all staff within the assigned area of CO including recruitment, training, mentoring, work assignments, performance evaluations and discipline of staff
  • Accountable for performance management, coaching and development of staff ensuring effective talent management
  • Plan career development and assess training requirements of CO employees and contractors
  • Responsible for the development of adequate training programs to maximize employee potential
  • Anticipate resource issues and plan remedial action. Assist with staff training and orientation for new employees
  • Develop staff by assigning them with their responsibilities, establishing goals that will increase knowledge / skill levels and delegate tasks commensurate with skill level
  • 10 years relevant experience is required with a MS/MPH, or 7 years with PharmD/PhD/MD
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, ARO or CRO. CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant
49

Executive Director Clinical Operations Resume Examples & Samples

  • 7 Years
  • 10 Years Preferred
  • Nursing degree and California state Registered Nurse license or MHA/MPH; clinical, administrative and supervisory experience
  • Thorough knowledge of management principles, clinical systems and operations, private practice administration, billing and collections, regulatory/accreditation agency requirements and quality assurance
50

Senior Director Clinical Operations Resume Examples & Samples

  • Bachelors Degree in Nursing or the equivalent
  • Current Registered Nurse in practicing state
  • Valid driver’s license and auto insurance
  • A minimum of ten years health care experience, including five years management experience in home health or hospice branch operations required
  • Strong knowledge of home health and hospice operations and regulations required
  • Excellent organizational, problem solving, decision-making, assertiveness, presentation and communication skills as well as the ability to travel are also required
51

Senior Director Clinical Operations, CCM Resume Examples & Samples

  • Demonstrates and promotes United HealthGroup’s Values and culture ensuring a positive shadow of leadership
  • Supports corporate and/or centralized initiatives at the regional and market levels
  • Leads markets in growth and problem solving via: Mentoring, Coaching and Training
  • Supports the development of market level clinical leaders, specifically, but not limited to Sr. DCOs/DCOs. Takes active role in new Market DCO orientation
  • Owns the relationship with the market Sr. DCOs/DCOs and VPs (plus additional market specific leadership including Medical Director, clinical, network and sales staff)
  • Acts as the clinical liaison to the Regional President, Medical Director finance, sales, and network leads
  • Communicates directly with VP of Clinical Field Ops around market/regional/clinical issues, concerns or process change
  • Identifies, develops, and implements best practices and processes
  • Communicates through written and verbal means to ensure efficiency of business and clinical practice success
  • Actively participates in the development and implementation of new products and processes nationally, regionally and locally at the market level
  • Coordinates consistent processes across markets and regions
  • Works with markets to ensure staffing needs are met in order to deliver desired outcomes in an efficient manner
  • Knows, interprets, and understands national, regional, and market trends, utilization, medical expense, revenue accuracy, quality measures and staffing efficiencies
  • Assists in the development and implementation of plans to reach national, regional and market specific targets
  • Actively participates in the development and implementation of new processes, products and models
  • Participates, supports and takes a leading role in the development and implementation of new technology
  • 4 year degree, Master’s degree preferred
  • 5+ years of experience managing large clinical teams
  • NP or PA required
  • 5 years of healthcare experience
  • Medicare experience highly preferred
  • Experience with healthcare analytics preferred
  • Proficient with Excel, Word, Outlook, PowerPoint
  • Up to 50% travel nationally