Project Manager

Novotech GlobalBay Lake, FL

About The Position

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.

Requirements

  • Solid understanding of the drug development and clinical trial process.
  • Solid understanding of the role and workings of a Clinical Research Organisation (CRO).
  • Solid understanding of ICH GCP.
  • Solid understanding of international and local regulatory requirements.

Responsibilities

  • Planning and management of all contracted responsibilities for assigned projects.
  • Act as primary contact between Novotech and client.
  • Lead and oversee 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.
  • Responsible for the overall project deliverables, leading the internal team and the financial performance of the project.
  • Responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope.
  • Identify and evaluate potential risks and develop risk management plans to mitigate this risk.
  • Contribute to process improvement initiatives.
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