Project Manager
Novotech Global Bay Lake, Florida, United States
Biotechnology Research · 1,001-5,000 employees
About the role
The Project Manager is responsible for planning and managing clinical projects from site selection to study close-out while ensuring compliance with regulations and internal SOPs. They act as the primary contact for clients and oversee internal teams to ensure projects are delivered on time and within budget.
What they look for
Requirements
Candidates must hold a graduate degree in a clinical or life sciences field and possess at least 5 years of experience in the clinical research industry. Previous project management experience is required, and experience within a Clinical Research Organisation (CRO) is considered advantageous.
Full description
The Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned projects. Act as primary contact between Novotech and client. Leads and oversees the execution of clinical projects in accordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. Project Manager is responsible for the overall project deliverables, leading the internal team and the financial performance of the project.
Project Managers are responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope. The Project Manager is responsible to identify and evaluate potential risks and develop risk management plans to mitigate this risk.
Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements.
PMs are expected to contribute to process improvement initiatives.
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