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Associate Director, Clinical Trial Delivery Unit, FSP Oversight Manager
BiogenAssociate Director managing Clinical Trial Delivery Unit overseeing FSP staff and operations. Leading resource management and fostering performance improvement in clinical trials.
About the role
Key responsibilities & impact- Manage up to 20 FSP staff assigned across the portfolio to deliver the CTDU’s program and study-level operational objectives.
- Lead resource forecasting and assignment to meet key business drivers and maximize FSP performance within annual operating plan.
- Develop and revise role-specific SOPs to drive consistency and quality across FSP staff.
- Design and implement training programs in collaboration with FSP vendors and CTDU stakeholders
- Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions and policy compliance.
- Represent CTDU in FSP vendor governance and oversight activities.
- Monitor and report applicable FSP role performance metrics.
- Partner with CTDU stakeholders to align on goals and promote continuous improvement.
Requirements
What you’ll need- Approximately 12 years of clinical research / project management experience preferably with both a sponsor company and/or FSP vendor managing insourced clinical trials.
- Line management experience is advantageous
- Excellent communicator and presenter
- Deep knowledge of project/program management skills
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchproject managementresource forecastingSOP developmenttraining program designperformance metrics monitoringpolicy compliance
Soft Skills
communicationpresentationleadershipcollaborationcontinuous improvement