Role & 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/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Immediately communicates/escalates responsible 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 CM project scope, budgeted hours, and timelines; manages patient- and site-level activities assigned to CM in the clinical or central monitoring plans to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt, with the oversight of the Lead CRA/Central Monitoring Lead (CML), 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.
- Assesses site data quality, risks and trends as well as operational performance and summarizes the findings for CRA review and action planning.
- Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation of the most relevant and actionable items for interpretation by CRAs and other functional roles assigned follow-up.

Preferred candidate profile : 5 + years of clinical trial monitoring experience

📌 Senior Central Monitor (Hyderabad)
🏢 Syneos Health
📍 Hyderabad