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About the role
Key responsibilities & impact- Provide subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials
- Support activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead
- Design and test CRFs, edit checks, reports, and listings
- Create documents, clean data, manage queries, and identify and mitigate risks
- Act as backup to the Clinical Data Lead and support cross-functional teams
- Apply data strategy and confirm use of global standards
- Assist in monitoring and reporting overall study progress
- Review study data comprehensively according to Biogen processes, regulatory guidelines, and study-specific plans
- Reconcile data collected in EDC with safety databases and external vendor systems
- Investigate issues and recommend solutions
- Review study metrics, communicate data topics across internal and external teams, and escalate issues for timely resolution
- Contribute to Data Management process creation, improvement, and innovation
- Support assessment of vendor quality and efficiency
- Participate in cross-functional collaborations, study-level activities, and special projects
Requirements
What you’ll need- Bachelor’s degree strongly preferred in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 4+ years of Clinical Data Management experience required
- Robust technical experience with Electronic Data Capture platforms, preferably Medidata Rave
- Experience using data review tools, preferably Elluminate
- Project management skills to effectively collaborate with various business functions
- Excellent written and oral communication skills in English
- 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
- Subject matter expertise among Clinical Data Management peers
Benefits
Comp & perks- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
- 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
- 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
- Opportunities for learning, growth, and expanding skills