Trial Delivery Specialist – Clinical Trial Coordination (FSP)

About the role

Thermo Fisher Scientific is seeking a Trial Delivery Specialist to join an embedded Functional Service Provider (FSP) team supporting a global biopharmaceutical client. In this execution‑focused position you will act as an extension of the client’s study team, ensuring operational excellence across all phases of clinical trials.

Key responsibilities

• Partner with global study leaders to monitor study conduct, identify risks, and drive corrective actions to meet quality, timeline, and budget goals.
• Set up and maintain internal systems, databases, and project plans from study initiation through archival.
• Review core clinical documents (protocols, informed consent forms) and support the development of monitoring, vendor, deviation, and risk management plans.
• Coordinate cross‑functional communication, schedule meetings, and facilitate interactions with regulatory bodies, CROs, and third‑party vendors.
• Act as primary point of contact for country oversight, tracking recruitment, data completeness, compliance, budgets, and import license status.
• Oversee vendor performance, manage CRO relationships, and ensure eTMF readiness for inspections.

Required profile

• Experience in clinical trial operations or coordination within a global biopharma or CRO environment.
• Strong understanding of study lifecycle, regulatory requirements, and vendor management.
• Ability to work collaboratively with internal and external stakeholders across multiple therapeutic areas.

Required skills

• eTMF oversight
• Vendor and CRO management
• Project planning and tracking tools