Sr. Clinical Trial Manager
Clinical | Mountain View, CA | Temporary
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.
- 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.