Sr Clinical Data Manager
About The Position
About This Role Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You’ll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and support to cross functional teams. Applies data strategy, confirms use of global standards, supports cross functional study team members, and assists in monitoring and reporting overall study progress. Accountable for comprehensive review of study data, ensuring all tasks are performed according to Biogen processes, regulatory guidelines, and study specific plans. Performs or oversees the reconciliation of data collected in EDC with other sources, such as the safety database and external vendor systems. Investigates issues and recommends solutions using experience, judgement, and precedent. Reviews study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution. Contributes to the development of Data Management process, including new process creation, process improvement, and innovation. Supports the assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers. Participates in cross-functional collaborations, including study level activities and special projects or initiatives. Who You Are You are recognized as a subject matter expert amongst Clinical Data Management peers. You enjoy supporting project teams, collaborating through thoughtful communication, and sharing and gaining Clinical Data Management knowledge to positively impact studies, programs, and the organization.
Requirements
- Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 4+ years of Clinical Data Management experience.
- Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and use of data review tools (elluminate preferred).
- Project management skills to effectively collaborate with various business functions.
- Excellent written and oral communication skills in English is required.
- Ability to effectively communicate with a variety of cross-functional teams in a variety of scenarios.
- High attention to detail, including proven ability to manage multiple competing priorities successfully.
- Understanding of drug development and the biopharmaceutical industry.
Responsibilities
- Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation.
- Act as the back up to the Clinical Data Lead, providing subject matter expertise and support to cross functional teams.
- Applies data strategy, confirms use of global standards, supports cross functional study team members, and assists in monitoring and reporting overall study progress.
- Accountable for comprehensive review of study data, ensuring all tasks are performed according to Biogen processes, regulatory guidelines, and study specific plans.
- Performs or oversees the reconciliation of data collected in EDC with other sources, such as the safety database and external vendor systems.
- Investigates issues and recommends solutions using experience, judgement, and precedent.
- Reviews study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
- Contributes to the development of Data Management process, including new process creation, process improvement, and innovation.
- Supports the assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers.
- Participates in cross-functional collaborations, including study level activities and special projects or initiatives.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
