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Clinical Trial Manager

Clinical Trial Manager (CTM / Clinical Study Manager / Clinical Operations) - Cambridge, MA

A pharmaceutical company in Cambridge, MA is looking for a Clinical Trial Manager to help with Rare Disease studies. The Clinical Trial Manager will be expected to be onsite 3 days a week.

Clinical Trial Manager (CTM / Clinical Study Manager / Clinical Operations) - Cambridge, MA

Responsibilities:

  • Manage the operational aspects of clinical trials
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
  • Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies
  • Work cross-functionally to ensure clinical program timelines and goals are met.
  • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
  • Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews

Qualifications:

  • 6+ years of clinical research experience
  • 3+ years of trial management experience
  • Previous experience managing complex global trials (i.e. rare disease, oncology, etc.)
  • Able to be onsite in Cambridge, MA 3+ days a week
  • Strong communication skills

If you are interested in this Clinical Trial Manager opportunity, please reach out to myself at j.segal(at sign)realstaffing.com.

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