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Clinical Trial Associate

Sr. Clinical Trial Associate- Cambridge, MA

Position Summary

Want an opportunity to join a growing global speciality-driven biopharmaceutical company? My client is seeking a Sr. Clinical Trial Associate with an entrepreneurial spirit and passion in speciality care to join one of their 115 cross-functional teams that span North America, Europe and Asia. This role assists in the delivery of Clinical Development objectives and achieve Clinical Excellence by taking responsibility on the TMF and study insurance request management, study budget & legal/administrative document tracking, CTMS updates and Transparency declarations.

Job Description

  • Assist the Global Clinical Project Manager (GCPM), Clinical Lead (CL) and Clinical Development Program Director (CDPD) on request.
  • Set up, administrate and QC check of various formats of e-TMF (e.g. CRO e-TMF/Ipsen e-TMF or paper TMF)
  • Create and update financial information within SAP (Internal Order, Purchase order, goods receipt & invoices) as well as financial trackers
  • Utilize K2 tool to create Commitment Requests and Clinical supplies coordination (k2 dispatch order)
  • Follow up on execution/signature of Clinical contracts and populate iCap with finalised contracts
  • Responsible for data entry within the CTMS with support of the CL or GCPM if needed
  • Study Insurances management: requests, follow-up and renewals

Qualifications

  • Bachelor's degree in science or related studies preferred
  • 1-2 years or more of experience supporting clinical trials at a CRO, Biotech or Pharmaceutical company preferred
  • Experience or knowledge of clinical study essential documents and regulatory documents, TMF
  • Familiar with medical terminology is recommended
  • Substantial administrative experience or qualified to degree level preferred

If you or a Sr. Clinical Trial Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at to discuss this role.

Thank you!

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