Serve as the lead study data manager on study teams and in collaboration with external vendors. Designs, implements and maintains electronic case report forms, clinical trial database and electronic edit checks for new and ongoing clinical research studies. Develops, implements and executes data review plans to ensure quality of collected clinical data, including oversight of multi-functional data review teams. Manages electronic data received from specialty vendors (e.g. clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics.
Exelixis is located in Alameda, CA.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide a high level of expertise in data management to support clinical studies.
- Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
- Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
- Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
- Support the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
- Prepare recommendations for new or improved processes for data management and data flow.
- No direct reports
- May direct the activities and hold accountable junior data managers and/or data review teams
- BS/BA degree in related discipline and seven years of related experience; or,
- MS/MA degree in related discipline and five years of related experience; or,
- PhD in related discipline and two years of related experience, or;
- AA degree with RN
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
- A minimum of 5 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
- Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
- Knowledge of GCP is essential.
- Expertise in CDISC standards preferred.
- Has extensive experience in relevant industry/profession and area of specialization.
- Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Identifies and implements methods and procedures to achieve results.
- Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
- Performs a variety of complicated tasks with a wide degree of creativity and latitude.
- Has complete understanding and wide application of technical principles, theories, concepts and techniques.
- Has good general knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.