Biogen is a global biotechnology company that discovers, develops, manufactures, and markets life-saving treatments for people with neurological, autoimmune, and rare diseases. Fou
Associate Director, Clinical Data Management
Location
California
Posted
7 days ago
Salary
$167K - $230K / year
Seniority
Senior
Job Description
Associate Director, Clinical Data Management
Biogen
• Accountable for providing Data Management expertise to assigned studies and/or programs by overseeing data quality and Data Management performance. • Ensures consistent implementation of data collection standards, data cleaning standards, and quality plans. • Contribute to the strategic development of the Data Management department, including processes, technology, data standards, reporting, process improvement, and innovation, and support the implementation of related process and system enhancements. • Responsible for the hiring, assignment, and development of staff within direct or indirect reporting lines. • Provide effective coaching and mentoring to ensure consistently high levels of performance and productivity. • Deliver ongoing feedback, coaching, and career development support, including engagement and retention activities, to maximize staff potential. • Act as a point of escalation for Data Management activities by interfacing with cross-functional customers. • Resolve complex issues through effective problem solving and appropriate escalation to senior management. • Research and resolve complex issues by leveraging appropriate resources and ensuring clear, thorough communication to support departmental awareness.
Job Requirements
- Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 12+ years relevant work experience in the Pharmaceutical/Biotech industry, with a focus on Clinical Data Management.
- In-depth understanding of drug development and the biopharmaceutical industry
- Subject matter expertise in Clinical Data Management process, quality management, and data standards development
- Robust technical experience with electronic data capture platforms (Medidata Rave preferred) and use of data review tools (elluminate preferred)
- Strong project management skills to effectively lead and collaborate with various business functions
- Demonstrated ability to establish effective processes and relationships with external stakeholders, including implementing process change
- High attention to detail, including proven ability to manage competing complex priorities successfully
- Experience supporting audits and inspections
- Demonstrated ability to influence without authority
- Excellent written and oral communication skills in English.
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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