Senior Clinical Trial Manager

Key Responsibilities:

• Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out.
• Drive study timelines, deliverables, and operational plans, ensuring alignment with overall program strategy.
• Monitor study metrics, including data quality, protocol deviations, and site performance, and drive appropriate follow-up actions.

Vendor and Cross-Functional Coordination:

• Oversee CRO and vendor activities, ensuring performance aligns with study expectations, timelines, budget, and quality standards.
• Support cross-functional coordination across Clinical, Regulatory, Data Management, Safety, and other stakeholders to ensure aligned study execution.
• Contribute to or own the development of key study documents such as protocols, ICFs, CRFs, and monitoring plans.

Leadership and Compliance:

• Mentor and provide day-to-day guidance to CTMs, CTMAs, and other junior team members.
• Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements, including timely TMF filing.
• Participate in study reviews, including data listings, protocol deviation review, and TMF quality, to identify trends and drive follow-up actions.