Study Start Up CTAU FSP Manager
About The Position
About This Role This role is part of the Clinical Trial Accelerator Unit (CTAU) and will partner with the Head of Study Start Up Operations to drive and manage its robust FSP insourcing model. This role oversees a team of FSP staff: including Regional Leads, SSU Specialists and Essential Document Reviewers to ensure fit for purpose resourcing and consistent approach, embedding efficient processes across the function. It ensures alignment with SSU’s key internal and external stakeholders on FSP role execution and performance to secure alignment in direction and delivery. What You’ll Do Provide day-to-day oversight of SSU FSP staff: eg Regional Leads, Study Start Up Specialists and Essential document reviewers, as required to deliver on Start Up activities across the portfolio. Be the point of contact for FSP service provider for SSU resourcing issues and questions. Lead resource forecasting and resource planning to meet key business drivers and maximize FSP performance within annual operating plan Real-time, agile resource allocation for EDP reviewer role as required Involves mapping out EDP reviews across all studies including amendments Real-time, agile allocation of SSU Specialists as required to ensure coverage for activations, along with amendments and yearly IRB submissions Oversee onboarding and offboarding of FSP resources including meet and greets, ensuring smooth transitions, training and policy compliance. Work with the start up team to develop and revise role-specific SOPs to drive consistency and quality across FSP staff Represent SSU group in FSP oversight activities and monitor and report applicable FSP role performance activities Partner with SSU stakeholders to align on goals and promote continuous improvement. Who You Are You are a leader responsible for forecasting, allocating, and overseeing study start-up FSP resources to deliver consistent, high-quality start-up activities across the portfolio. You support teams through hands-on resource planning, clear processes, targeted training, and close collaboration to ensure, workloads are balanced, and delivery remains consistent and effective.
Requirements
- B.A. or B.S. in a scientific discipline; advanced degree preferred
- 10+ years in Clinical Research with 5+ years in global start-up
- Start Up experience across multiple studies and programs, with the agility to adapt to an evolving pipeline and with the ability to apply this knowledge to inform resource demand forecasting and algorithm refinement
- Proven ability to manage and oversee FSP staff, including resource planning, training, and performance management.
- Ability to leverage comprehensive knowledge of key business drivers to maximize FSP staff performance.
- Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels.
- Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, and team building.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
- Strong project management capabilities with a proactive mindset
- Collaborative mindset with the ability to partner effectively with internal and external stakeholders.
Responsibilities
- Provide day-to-day oversight of SSU FSP staff: eg Regional Leads, Study Start Up Specialists and Essential document reviewers, as required to deliver on Start Up activities across the portfolio.
- Be the point of contact for FSP service provider for SSU resourcing issues and questions.
- Lead resource forecasting and resource planning to meet key business drivers and maximize FSP performance within annual operating plan
- Real-time, agile resource allocation for EDP reviewer role as required Involves mapping out EDP reviews across all studies including amendments
- Real-time, agile allocation of SSU Specialists as required to ensure coverage for activations, along with amendments and yearly IRB submissions
- Oversee onboarding and offboarding of FSP resources including meet and greets, ensuring smooth transitions, training and policy compliance.
- Work with the start up team to develop and revise role-specific SOPs to drive consistency and quality across FSP staff
- Represent SSU group in FSP oversight activities and monitor and report applicable FSP role performance activities
- Partner with SSU stakeholders to align on goals and promote continuous improvement.
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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What This Job Offers
Job Type
Full-time
Career Level
Manager
