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Clinical Project Manager - Waltham, MA

Clinical Project Manager- Cambridge, MA

The Company:

A highly successful pharmaceutical corporation is seeking to hire a l Clinical Project Manager (CPM) for their biopharmaceutical hub. As a Clinical Project Manager (CPM), you will be part of an innovative network that targets to treat debilitating diseases.

The Role:

The Clinical Project Manager (CPM) will be responsible for: 1) Ensuring efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up to verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation. 2) Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members. 3) Preparing, assisting and/or validating all clinical study documents such as study manuals, monitoring plans, oversight plan that was prepared by the Clinical CRO.

Required Skillset/Background:

  • Minimum of 5-years of experience as a clinical Project Manager working for a biotech or pharmaceutical company
  • The ideal candidate must have strong project management skills, be able to be a leader, work independently, highly organized and be able to prioritize different tasks.
  • Oncology or rare disease experience is a PLUS
  • Must have experience preparing clinical study documents from study set up, maintenance and closing.
  • Must have experience in managing and developing relationships with Contract Research Organizations (CROs).
  • The Global Clinical Project Manager (CPM) should have good knowledge of Good Clinical Practice (GCP), ICH regulations.
  • Education Requirement: Bachelor's degree in life sciences or a Medical Graduate, or other relevant qualifications.

If you or a Clinical Project Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Business in relation to this vacancy.