Senior Clinical Trial Manager

3 weeks ago


South San Francisco, United States EPM Scientific Full time

Salary: $160 - $200K

Location: South San Francisco, CA (Hybrid - must be local)


Company Summary: Working with the C-suite of a precision IO biotechnology company to build out their clinical operations team in an effort to develop best-in-class immunotherapies to address unmet needs within the oncology space. Their pipeline consists of 1 Phase Ib asset and 4 more preclinical assets. They are looking for a Sr. Clinical Trial Manager to join the team on a full-time basis.


Responsibilities:

  • Managing all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities
  • Identifying potential study issues/risks and recommends/implements solutions.
  • Managing CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contacts
  • Contributing to the writing, review and finalization of protocols or components of clinical study report
  • Organizing clinical operational meeting
  • Developing and maintaining strong working relationships with principal investigators, key clinical opinion leaders and site
  • May be responsible for contributing to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and /or change order
  • Developing strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trials
  • Ensuring adherence with SOP, applicable regulations, GCP, and ICH guidelines
  • Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc.
  • Attend and/or present at Investigator Meetings as needed


Requirement

  • At least 5 years of industry (must be at a sponsor) experience REQUIRED
  • 3 years of early phase trial management experience (oncology strongly preferred)
  • Global and early phase trial experience preferred
  • A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline
  • A working knowledge of ICH GCP guidelines


Benefits:

  • Pre-IPO biotech company
  • Competitive salary with comprehensive benefits (90% medical coverage)
  • Flexible PTO and WFH arrangements
  • 401K contribution
  • Cell phone reimbursement, life insurance, and additional perks


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