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Associate Director, Country Site & Operations FSP Oversight Manager

biibhr · Baar

New
Senior 🇬🇧 English
GCP ICH guidelines project management

Job description

About the role

The Associate Director, Country Site & Operations FSP Oversight Manager will lead the Functional Service Provider (FSP) team within the Country & Site Operations (CSO) function. Partnering with CSO leadership and cross‑functional stakeholders, you will drive the insourcing model, ensure consistent processes, and support clinical trial execution across regions and therapeutic areas.

Key responsibilities

  • Manage 20‑25 FSP staff supporting country‑ and site‑level operational objectives.
  • Lead resource forecasting, assignment and prioritisation to meet regional delivery needs and annual operating plan commitments.
  • Develop and implement role‑specific processes, guidance and quality expectations for FSP staff.
  • Design and deliver training and onboarding programmes in collaboration with vendors and CSO leaders.
  • Oversee onboarding/off‑boarding of FSP resources, ensuring policy compliance and continuity.
  • Represent CSO in FSP vendor governance, oversight and performance management forums.
  • Monitor and report FSP performance metrics, quality indicators, workload trends and delivery risks.
  • Partner with regional leaders, study teams, Medical, Quality and other stakeholders to align goals and promote continuous improvement.

Required profile

  • Approximately 12 years of experience in clinical research, clinical operations, country/site operations or project management.
  • Strong leadership, organisational and mentoring abilities.
  • Proven experience managing resources, vendors and cross‑functional stakeholders.
  • Deep understanding of drug development phases I‑IV and regulatory environments.

Required skills

  • Knowledge of GCP and ICH guidelines.
  • Familiarity with regulatory requirements and quality expectations for global clinical development.
  • Project management capabilities.

Questions fréquentes

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Source : ats:workday

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Published 4 hours ago

Expires 1 month from now

4 views · 0 interested

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biibhr

Baar