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Sr. Clinical Trial Manager

Clinical | Mountain View, CA | Temporary

Job Description

Position Summary

This is a 6-month temporary assignment.

Reporting to Executive Director, Clinical Operations, the Senior Clinical Trial Manager will be responsible for the day-to-day management of ChemoCentryx clinical trials, including management of contract CROs conducting company sponsored clinical trials.


Responsibilities:

  • Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
  • Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
  • Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
  • Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
  • Coordinate/plan investigator meetings and/or site and CRA training.
  • Perform financial management, including review and approval of site and vendor invoices.
  • Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
  • Perform review and QC central clinical files and trial master file.
  • Identify potential study issues and recommend and implement solutions or corrective actions as needed.
  • Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
  • Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
  • Organize and manage internal team meetings and other trial-specific meetings.
  • Participating in the development, review and implementation of departmental SOPs and processes.