Manager, Functional Service Provider (FSP) 360

About the role

Syneos Health is seeking a Manager, FSP 360 to lead clinical monitoring and site management activities for its Functional Service Provider partnerships. The role ensures high‑quality deliverables, aligns activities with budgets, and supports the study team throughout the trial lifecycle.

Key responsibilities

• Oversee clinical monitoring and site management deliverables, develop Clinical Management Plans (CMP) and Site Management Plans (SMP), and maintain visibility using approved tracking tools.
• Interact with clients and internal functional departments, ensure alignment with budget, and participate in business development proposals.
• Lead training for study teams on protocol specifics, CRF completion, SOPs, and data plans; conduct regular study team calls for status updates.
• Review and approve site monitoring documentation, assess site processes, perform Source Document Verification (SDV), and develop corrective action plans based on risk assessments.

Required profile

• Strong experience in clinical monitoring, site management, and functional service provider environments.
• Ability to evaluate staff competency, manage budgets, and ensure compliance with ICH/GCP, GPP, and local regulations.

Required skills

• Proficiency with Clinical Trial Management Systems (CTMS) and electronic Case Report Forms (eCRF).
• Knowledge of IVRS/IWRS enrollment systems and data visualization dashboards.
• Familiarity with source document verification (SDV) and risk‑based monitoring strategies.