Job Title: Oversight Monitor
Job Location: Singapore
Position Summary
The Oversight Monitor provides independent oversight of clinical monitoring activities performed by Contract Research Organizations (CROs) and/or third-party vendors to ensure sponsor compliance with ICH-GCP (E6 R2/R3), applicable regulatory requirements (FDA, EMA, Health Canada, MHRA, etc.), and the sponsor's Quality Management System (QMS).
This role focuses on evaluating the quality, consistency, and adequacy of site monitoring, issue management, and documentation practices to ensure trial integrity, subject safety, and data reliability.
Duties And Responsibilities
- Provide continuous oversight of CRO-conducted monitoring activities to ensure compliance with the study protocol, Monitoring Plan, SOPs, regulatory and GCP requirements.
- Perform remote and on-site oversight visits to evaluate CRA performance and site quality.
- Review monitoring visit reports, follow-up letters, issue logs, and escalation processes to assess adequacy and timeliness.
- Track and trend CRO performance metrics and KPIs; identify systemic issues and areas for improvement.
- Support root cause analysis and CAPA development related to monitoring or site performance.
- Contribute to development and or maintenance of risk-based Monitoring Oversight Plan.
- Implement risk-based quality oversight strategies in alignment with the Monitoring Oversight Plan and Quality Risk Management Plan.
- Evaluate protocol-specific risks related to patient safety, data quality, and site operations.
- Verify that CRO(s) and CRAs follow appropriate risk identification and mitigation measures.
- Maintain oversight documentation, Monitoring Oversight Visit reports, and issue-tracking logs per SOP requirements.
- Prepare and deliver periodic oversight summaries for leadership review.
- Ensure site inspection readiness.
- Ensure audit/inspection readiness of all oversight documentation and participate in inspections or audits as required.
- Provide feedback and guidance to CRO CRAs regarding quality expectations, data integrity, and GCP compliance.
- Collaborate with cross-functional teams (Clinical Operations, Data Management, QA, and Vendor Management) to support continuous improvement.
- Participate in oversight governance meetings and contribute to vendor performance reviews.
- Serve as the primary liaison between study sites and the sponsor.
- Build trusted partnerships with investigators and site staff to enhance collaboration and ensure site needs are recognized and met.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field (advanced degree preferred).
- Minimum 5–7 years of clinical research experience, including at least 3 years of on-site monitoring.
- Minimum 2 years of hands-on Monitoring Oversight experience including on-site oversight visits as a Lead CRA or OM.
- Prior experience in CRO/vendor management is strongly preferred.
- Thorough understanding of ICH-GCP, E6 R2/R3, and applicable regional regulations.
- Demonstrated experience in inspection readiness and CAPA management.
- Strong analytical, documentation, and communication skills.
- Ability to travel for oversight visits nationally in USA (approximately 70%).
- Excellent communication, organizational, and problem-solving abilities.
- Neurology experience required
- Experience overseeing eCOA/ePRO (e.g. Signant) vendor preferred.
- Experience with Veeva Vault CTMS
Skills: risk-based monitoring,documentation,oversight,management,neurology,veeva vault ctms,clinical research associate,compliance
