The Senior Clinical Trials Manager Sr. (CTM) is accountable for executing multiple concurrent, complex clinical trials on-time and within budget in a highly dynamic and complex global environment. This professional will be brought on board to support a study currently being conducted in central Africa (Ghana). It would be a huge plus if the desired candidate had experience managing studies in this region. Depending on experience in the area the client might also consider someone with less experience. Anti-Infective Drug / Vaccine exp preferred.
- Collaborate with the Program Management team to create and maintain study timelines, risk registry and operational logistics and assess study progress to ensure all stakeholders are informed and aligned on trial deliverables.
- Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met.
- Responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial.
- Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management, manage internal and external expectations and deliverables through communication and influence.
- Lead Study Team Meetings including Study Kick-off Meetings, and may participate in Core Team meetings
- Manage and oversee the coordination of study start-up, conduct and close-out activities
- Oversee Investigational Product Management (labelling, packaging, shipping, temperature excursions, accountability/reconciliation, destruction)
- Manage and oversee monitoring and co-monitoring visits and trip report reviews according to the Clinical Monitoring Plan
- Ensure and oversee tracking of subject status throughout the study at investigative sites through collaboration with data management by monitoring subjects’ safety trends and alerts, and protocol deviations
- Responsible for data integrity and accuracy throughout the Clinical Trial lifecycle.
- Assure appropriate oversight for collection and tracking clinical samples from clinical sites to central labs and vendors
Duration: 12 Months +
Start Date: 12/5
Remote: Senior Clinical Trials Manager (232107)