Project Manager, Gen Med
Overview The Project Manager is responsible for planning and managing all contracted activities for assigned Gen Med clinical projects. This role serves as the primary contact between Novotech and the client and leads the execution of clinical studies in accordance with local regulations, ICH GCP guidelines, Novotech/client SOPs, and the Project Agreement to deliver projects on time and within budget. The Project Manager oversees the overall project deliverables, coordinates the internal team, and manages the project’s financial performance from site selection through close-out, including all deliverables within scope.
Project Manager, Gen Med
Overview The Project Manager is responsible for planning and managing all contracted activities for assigned Gen Med clinical projects. This role serves as the primary contact between Novotech and the client and leads the execution of clinical studies in accordance with local regulations, ICH GCP guidelines, Novotech/client SOPs, and the Project Agreement to deliver projects on time and within budget. The Project Manager oversees the overall project deliverables, coordinates the internal team, and manages the project’s financial performance from site selection through close-out, including all deliverables within scope.
Responsibilities - Determine project feasibility and scope in collaboration with the sponsor and Business Development. - Guide and review scope of work, timelines, responsibilities, and quality of deliverables. - Ensure compliance with the Project Agreement; identify risks and implement contingencies. - Set up and maintain project plans, timelines, study tracking tools (CTMS), and eTMF as required. - Collaborate with Vendor Manager to select and manage vendors (central labs, drug distributors, IRT, etc.). - Manage the study budget and revenue, adjust forecasts, and monitor profitability. - Communicate changes in procedures or progress that impact revenue; manage scope changes with client and BD. - Select and manage investigational sites to meet objectives and timelines; ensure high-quality ethics & regulatory submissions; manage logistics and site activation documents
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Responsibilities - Determine project feasibility and scope in collaboration with the sponsor and Business Development. - Guide and review scope of work, timelines, responsibilities, and quality of deliverables. - Ensure compliance with the Project Agreement; identify risks and implement contingencies. - Set up and maintain project plans, timelines, study tracking tools (CTMS), and eTMF as required. - Collaborate with Vendor Manager to select and manage vendors (central labs, drug distributors, IRT, etc.). - Manage the study budget and revenue, adjust forecasts, and monitor profitability. - Communicate changes in procedures or progress that impact revenue; manage scope changes with client and BD. - Select and manage investigational sites to meet objectives and timelines; ensure high-quality ethics & regulatory submissions; manage logistics and site activation documents
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