Analyst within Credit Risk Management team identifying credit segmentation opportunities using statistical methods. Collaborating with teams to enhance credit decision process and policies.
About the role
- Provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials
- Manages the flow of all Clinical Data throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR)
- Ensure effective project planning, risk management and provision of high-quality data deliverables
- Leads the design and development of eCRFs, ensuring adherence to Biogen standards throughout
- Coordinates the development and testing of data management system edit checks and the listings/reports/tools utilized for the data review and discrepancy management activities
- Develops Data Management Plan documents utilized to deliver accurate, timely, consistent, and quality clinical data
- Acts as the primary and accountable Data Management (DM) representative to the study management team
- Partners with key cross functional team members to develop and implement project plans for assigned studies
Requirements
- 7+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock for Principal Clinical Data Lead
- 10+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock for Senior Principal Clinical Data Lead
- Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as eCS elluminate
- Deep understanding of drug development and biopharmaceutical industry required
- Exceptional project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- High attention to detail including proven ability to manage multiple, competing priorities
- Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
- Deep knowledge of clinical data management outsourcing operating model to functional-service providers and full-service/global CROs
- Demonstrated ability to influence without authority
- Excellent written and oral communication skills
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
Job title
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Experience level
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Degree requirement
No Education Requirement
Location requirements
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