Description
Syneos Health is seeking a Senior Central Monitor I to join their Clinical Solutions team. The successful candidate will have a good understanding of Risk-Based Quality Management (RBQM), patient-level data review and analysis experience, and data analytics expertise.
Job Responsibilities
- Review and understand protocol, critical data, and process, safety, and data integrity risks related to protocol execution
- Review patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues, and illogical/inaccurate/missing data
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Document observations noted during reviews and write queries, protocol deviations, or action items as necessary
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Access vendor systems or reports to verify IP has been dispensed and administered to subjects/patients according to the protocol
- Document completion of activities via tracking, reporting, and/or other required project documents
- Understand CM project scope, budgeted hours, and timelines, and manage patient- and site-level activities assigned to CM
- Adapt to changing priorities to achieve goals/targets
- Prepare for and attend Investigator Meetings and/or sponsor meetings, and participate in project staff meetings
- Assess site data quality, risks, and trends, and summarize findings for CRA review and action planning
- Utilize KRI dashboards, metrics, and reporting systems to synthesize data trends, issues, and action items
Additional Information
- Tasks, duties, and responsibilities as listed in this job description are not exhaustive
- The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities