Description
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Job Responsibilities
- Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
- Must have good understanding of Risk-Based Quality Management (RBQM), Patient-level data review and analysis experience, Data analytics expertise, Ability to identify risks, safety signals, and efficacy trends proactively.
- Reviews 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.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
- Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.
- Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
- For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, to changing priorities to achieve goals/targets.
- Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.
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.