Associate Director, Clinical Data Management

Exelixis-posted 3 months ago

$176,500 - $250,000/Yr

Full-time • Senior

Alameda, CA

1,001-5,000 employees

Professional, Scientific, and Technical Services

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Oversees, develops and manages clinical data management activities while collaborating and coordinating with other departments. Oversees the evaluation, integration and implementation of new clinical systems and technologies for clinical trial management activities including electronic data capture and documentation systems.

Provides a high level of expertise in data management to support clinical studies, including areas such as: Case Report Form (CRF) design, database design, data management plans, edit checks/quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, and database lock.
Manages time and resource constraints across multiple projects.
Develops and implement new or improved processes for data management.
Effectively manages Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget.
Participates in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
Provides oversight on quality and timeliness of task completion by direct reports.
Develops and implement training curriculum for data management activities and principles as required.

BS/BA degree in related discipline and a minimum of 11 years of related experience; or, MS/MA degree in related discipline and a minimum of 9 years of related experience; or, PhD in related discipline and a minimum of 5 years of related experience, or; Equivalent combination of education and experience.
Typically requires a minimum of 14 years of related experience or the equivalent combination of experience and education/training.
Experience in Biotech/Pharmaceutical industry preferred.
Demonstrated experience leading data management teams is required.
Experience participating in regulatory submissions and inspections is required.
A minimum of 7 years of line management experience is required.

401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan for field sales staff
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in the first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year

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