Associate Director, Country & Site Operations FSP Oversight Manager

Biogen

7d•$171,000 - $235,500

About The Position

The Associate Director, Country & Site Operations Functional Service Provider (FSP) Oversight Manager partners with CSO leadership and cross-functional stakeholders to drive and manage CSO’s FSP insourcing model. This role oversees and develops FSP staff supporting country- and site-facing clinical trial execution, embedding consistent, efficient processes across regions and therapeutic areas. It ensures alignment with CSO’s internal and external stakeholders on FSP role execution, performance, quality, and delivery expectations. This role also contributes to shaping CSO operational strategy and continuous improvement as part of the CSO extended leadership model.

Requirements

Bachelors degree in a scientific discipline; advanced degree preferred.
8+ years of clinical research, clinical operations, country/site operations, or project management experience, preferably with both a sponsor company and/or FSP vendor supporting insourced clinical trial delivery.
Experience managing resources, vendors, and cross-functional stakeholders is required; line management experience is advantageous.
Proven ability to manage and oversee FSP staff, including resource planning, training, performance management, and workload prioritization.
Ability to leverage strong knowledge of country and site operations, clinical trial execution, and key business drivers to maximize FSP staff performance.
Strong cross-functional knowledge of drug development and expertise in clinical trial phases I–IV, including country activation, site engagement, study conduct, and inspection readiness.
Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels and geographies.
Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, stakeholder management, and team building.
In-depth knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.
Strong project management capabilities, including risk assessment, contingency planning, vendor oversight, and issue escalation within an insourced FSP model.
Collaborative, site-centric mindset with the ability to partner effectively with internal and external stakeholders to drive consistent delivery and continuous improvement.

Responsibilities

Manage up to 20-25 FSP staff assigned across the clinical portfolio to support CSO’s country and site-level operational objectives.
Lead resource forecasting, assignment, and prioritization to support regional delivery needs, portfolio demand, and annual operating plan commitments.
Support FSP budget forecasting and financial oversight, partnering with CSO leadership to optimize resource utilization and external spend.
Develop, refine, and implement role-specific processes, guidance, and quality expectations to drive consistency across FSP staff supporting CSO activities.
Design and implement training and onboarding programs in collaboration with FSP vendors, CSO leaders, and key cross-functional stakeholders.
Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions, role clarity, policy compliance, and continuity of country and site support.
Represent CSO in FSP vendor governance, oversight, and performance management forums.
Monitor, analyze, and report applicable FSP role performance metrics, quality indicators, workload trends, and delivery risks.
Partner with CSO regional leaders, study teams, Medical, Quality, and other stakeholders to align on goals, strengthen site-centric execution, and promote continuous improvement.
Drive continuous improvement and evolution of the FSP operating model, identifying opportunities to improve scalability, efficiency, role clarity, quality, and cost effectiveness.

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