Job Description
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.
Responsabilities:
1. Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents.
2. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.
3. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.
4. Conduct oversight site visits includi...