Location: Remote
Summary
The 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 Manager, Clinical Site Operations will ensure ongoing inspection readiness, data integrity and overall data quality according to and in compliance with corporate and project/program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- 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 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
- 30% of travel required
Education and Experience
- Bachelor’ degree
- At least 6+ years of experience in Clinical Operations
Skills and Qualifications
- Has skills and expertise in oversight, mentoring and coaching of CRAs
- Independent professional who proactively communicates frequently and effectively.
- 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
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
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