Senior Specialist, Clinical Trial Management

Clinical Trial Manager (CTM), Translational Medicine And Early Development (TMED)

The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in the operational aspects of phase 1 & phase 2a studies and will report to the Executive Director, TMED Operations. The CTM will support the TMED Operations Lead to plan and execute studies including, but not limited to, managing study timelines, reviewing / approving study-related documents and serving as the primary point of contact for study vendors. The CTM will also assist in managing the clinical study team and help to coordinate meetings and interactions with vendors to optimize communication and execution of TMED studies.

Responsibilities :

• Manage and support the operational aspects of clinical studies from study start-up through close-out.
• Manage and serve as the point of contact for study-related vendors, including the study contract research organization (CRO) and / or clinical study sites or other vendors, as appropriate, to execute TMED studies in accordance with contracted scope, costs and timelines.
• Actively engage with vendors on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities.
• Coordinating internal and external cross-functional communication and documentation to optimize collaboration and ensure TMED studies are executed with the highest standards and are conducted in compliance with the protocol, ICH / GCP, and applicable regulatory requirements.
• Identify risks to ensure successful execution of TMED studies, proactively communicate risks to internal and external cross-functional teams and vendor teams, and manage the clinical study team to develop and implement risk mitigation strategies and tactics to enable study completion in accordance with approved timelines and plans.

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