Sr. Manager/Manager, Clinical Site Operations

Background:

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Position Summary:

The Sr. Manager/Manager, Clinical Site Operations is responsible for the oversight and management of study execution activities at our clinical investigative sites. This includes oversight and management of Clinical Research Organization (CRO), Clinical Research Associates (CRAs) / monitors and Investigator Sites. The Sr. Manager/Manager, Clinical Site Operations will ensure ongoing inspection readiness, data integrity and overall data quality.

Major Accountabilities:

  • Responsible for the oversight and management of assigned clinical sites and studies. This includes ensuring site execution of studies in accordance with RayzeBio SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection
  • Oversight of all CRO work to ensure:
    • Appropriate training of the clinical team and investigators
    • Timely start-up
    • Site payments are completed in a timely manner
  • Perform review and quality control of trial master file, ensuring overall inspection readiness
  • Perform review of safety data to ensure all outstanding items are addresses within a timely manner
  • Utilize CRO systems to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality. If items are identified that would require re-training the Sr. Manager/Manager will facilitate
  • Proactively identify, prevent, and mitigate site-specific study-related risks
  • Summarizes clinical site performance data and escalates risk to the Sr. Director CSO and SVP, Clinical Operations, as needed
  • Contributes to the development, review and approval of site and study documents including but not limited to RayzeBio SOPs and Clinical Operation Plans
  • Conduct site visits to foster site relationships with RayzeBio, address poor performance, increase site interaction and enrollment, and further ensure adequate oversight of study execution
  • Serve as the direct sponsor contact for sites
  • Participate in departmental initiatives
  • Has skills and expertise in oversight, mentoring and coaching of CRAs
  • Detail oriented, organized and committed to quality and consistency
  • Excellent team-interaction skills and ability to work successfully in cross-functional teams
  • Ability to work in a dynamic environment with a high degree of flexibility

General:

  • Department: Clinical Operations and reports to: Senior Director, Clinical Site Operations
  • Location: Remote, Willing to travel up to 30% (US and global travel)
  • Monitoring oncology-solid tumor experience required

Salary Range: $95,000 to $150,000

Benefits:

  • Medical, Dental and Vision plans
  • Life, Accidental Death, Personal Loss, and Disability
  • Flexible Spending Account (FSA)
  • 401(k) Retirement Plan
  • Equity/stock options
  • Paid Time Off
  • Company paid holidays

To apply, please send CV to jobs@rayzebio.com