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.

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.

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

Study Start Up CTAU FSP Manager

Key skills