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Clinical Program Manager

Sr. Clinical Program Manager- Cambridge, MA (1-2 Day Remote Flexibility)

Overview:

Looking to join a growing biotechnology company pioneering precision therapeutics for patients with high-risk genetic profiles? My client is looking for a Clinical Program Manager that will report to the Vice President of Clinical Operations. The CPM will be responsible for developing, managing and implementing single and multi-site clinical trials or a suite of studies to required quality standards, ensuring the integrity of the clinical data on schedule and within budget for phase I-IV clinical trials by supervising outside vendors and contractors.

Responsibilities:

  • Develop and manage study timelines, milestones and budgets in collaboration with trial team members
  • Develop case report forms, informed consent forms and other study-related documents
  • Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical trials are executed properly, on time and in compliance with GCPs
  • Conducts and/or delegates, site evaluations/initiation/monitoring and closeout visits, as required
  • Leads development of Clinical Study Reports, contributes to NDAs, and other clinical/regulatory/safety documents.- ensuring reports are controlled for quality, signed off and published with copies going to Regulatory Authorities and Ethics Committees, as required
  • Oversees collection and archival of all necessary documents for inclusion in the Trial Master File
  • Ensure study compliance by understanding and applying all relevant SOPs

Requirements:

  • Bachelor of Science degree in a relevant scientific discipline preferred
  • 6-8 years of Clinical Program Management experience
  • Ophthalmology or Rare Disease preferred
  • 6+ years of CRO Vendor Management preferred

If you or a Sr. Clinical Program 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 M.Hamdeh (at sign) Realstaffing.com to discuss this role.

Thank you!

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