Study Start Up CTAU FSP Manager
Biogen
4 months ago
Remote friendly (United States)
United States
Clinical Research and Development
What You’ll Do
- Provide day-to-day oversight of SSU FSP staff (e.g., Regional Leads, Study Start Up Specialists, Essential Document Reviewers) to deliver Start Up activities across the portfolio.
- Serve as the point of contact for FSP service provider resourcing issues and questions.
- Lead resource forecasting and resource planning to meet key business drivers and maximize FSP performance within the annual operating plan.
- Perform real-time, agile resource allocation for EDP reviewers, including mapping EDP reviews across all studies (including amendments).
- Perform real-time, agile allocation of SSU Specialists to ensure coverage for activations, amendments, and yearly IRB submissions.
- Oversee onboarding and offboarding of FSP resources (including meet and greets), ensuring smooth transitions, training, and policy compliance.
- Develop and revise role-specific SOPs with the start up team to drive consistency and quality across FSP staff.
- Represent the SSU group in FSP oversight activities; monitor and report applicable FSP role performance activities.
- Partner with SSU stakeholders to align on goals and promote continuous improvement.
Required Qualifications/Skills
- 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; ability to adapt to an evolving pipeline and inform resource demand forecasting and algorithm refinement.
- Proven ability to manage/oversee FSP staff, including resource planning, training, and performance management.
- Ability to leverage key business drivers to maximize FSP performance.
- Effective line management and mentoring skills; builds strong relationships across organizational levels.
- Excellent leadership, communication, and organizational skills; 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 effective partnership with internal and external stakeholders.
Benefits
- Base compensation range: $134,000.00–$179,000.00
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness programs (fitness reimbursement)
- Short- and Long-Term Disability insurance
- Paid vacation (minimum 15 days) and 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
- 401(k) with company matched contributions; Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation
- Provide day-to-day oversight of SSU FSP staff (e.g., Regional Leads, Study Start Up Specialists, Essential Document Reviewers) to deliver Start Up activities across the portfolio.
- Serve as the point of contact for FSP service provider resourcing issues and questions.
- Lead resource forecasting and resource planning to meet key business drivers and maximize FSP performance within the annual operating plan.
- Perform real-time, agile resource allocation for EDP reviewers, including mapping EDP reviews across all studies (including amendments).
- Perform real-time, agile allocation of SSU Specialists to ensure coverage for activations, amendments, and yearly IRB submissions.
- Oversee onboarding and offboarding of FSP resources (including meet and greets), ensuring smooth transitions, training, and policy compliance.
- Develop and revise role-specific SOPs with the start up team to drive consistency and quality across FSP staff.
- Represent the SSU group in FSP oversight activities; monitor and report applicable FSP role performance activities.
- Partner with SSU stakeholders to align on goals and promote continuous improvement.
Required Qualifications/Skills
- 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; ability to adapt to an evolving pipeline and inform resource demand forecasting and algorithm refinement.
- Proven ability to manage/oversee FSP staff, including resource planning, training, and performance management.
- Ability to leverage key business drivers to maximize FSP performance.
- Effective line management and mentoring skills; builds strong relationships across organizational levels.
- Excellent leadership, communication, and organizational skills; 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 effective partnership with internal and external stakeholders.
Benefits
- Base compensation range: $134,000.00–$179,000.00
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness programs (fitness reimbursement)
- Short- and Long-Term Disability insurance
- Paid vacation (minimum 15 days) and 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
- 401(k) with company matched contributions; Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation