Clinical Study Manager

7 days ago

Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time
Job Summary

Summit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Specialist to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, and ensure accurate and timely documentation.

Key Responsibilities
  • Administrative Support: Provide administrative support to clinical operations study teams, including managing meeting logistics, creating agendas, and drafting meeting minutes.
  • Task Execution: Execute tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking.
  • Documentation: Ensure accurate and timely documentation, including eTMF management, study contracts, and financial records in compliance with ICH-GCP, company policies, and regulatory requirements.
  • Cross-Functional Coordination: Coordinate clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation.
  • Study Materials: Create and maintain study-related materials, such as country and site binders and tracks trial milestones.
  • eTMF Management: Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF.
  • Data Collection: Collaborate with CROs to ensure accurate data collection and entry into the CTMS and EDC.
  • Team Meetings: Attend and contribute to team meetings, taking detailed meeting minutes.
  • Process Improvement: Actively participate in process improvement initiatives to enhance clinical operations efficiency.
Requirements
  • Experience: 3+ Years of experience in clinical study environment within CRO or Pharmaceutical company.
  • Knowledge: Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out.
  • Skills: Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
  • Education: Bachelor's degree in a related field.
  • Software Skills: Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
What We Offer
  • Compensation: The pay range for this role is $110,000 to $130,000 annually.
  • Benefits: Health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

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