Central Report Reviewer (CRR)
Company: Syneos Health
Location: Pune, India
Job ID: 25109861
Updated On: June 29, 2026
Job Summary
Syneos Health is hiring a Central Report Reviewer (CRR) to review and approve clinical monitoring reports for Phase I–IV clinical trials. The role focuses on ensuring compliance with study protocols, ICH-GCP, regulatory requirements, patient safety, and data integrity. The CRR reviews site and central monitoring documentation, identifies compliance risks, supports monitoring activities, and collaborates with Clinical Trial Managers (CTMs), CRAs, and project teams to ensure high-quality clinical trial execution.
Key Responsibilities
Perform Central Report Review (CRR) activities for assigned clinical studies.
Review and approve site monitoring reports and central monitoring reports.
Ensure compliance with study protocols, ICH-GCP, SOPs, and regulatory guidelines.
Assess patient safety, protocol compliance, and data integrity.
Review site visit reports including PSV, SIV, IMV, COV, and SCAN reports.
Evaluate the quality and completeness of monitoring documentation.
Review site monitoring calls, visit reports, site letters, and project correspondence.
Document report revisions and approvals in the Clinical Trial Management System (CTMS).
Identify protocol deviations, GCP violations, and pharmacovigilance issues.
Escalate critical compliance and patient safety issues to Clinical Trial Managers (CTMs) and Project Managers.
Track action items and ensure timely follow-up by CRAs and project teams.
Assess CRA and Clinical Monitor report quality and identify operational trends.
Prepare summaries and findings for CTM review and action planning.
Participate in project meetings, clinical training, and cross-functional discussions.
Maintain awareness of project status through regular communication and documentation review.
Required Skills
Clinical Monitoring
Central Report Review (CRR)
Clinical Trial Management
ICH-GCP Compliance
Clinical Trial Documentation
Site Monitoring Reports
Central Monitoring Reports
Protocol Compliance
Data Integrity
Patient Safety
Risk Assessment
Protocol Deviations Management
CTMS (Clinical Trial Management System)
Pharmacovigilance Awareness
Quality Review
Clinical Operations
Attention to Detail
Critical Thinking
Analytical Skills
Communication & Documentation
Eligibility
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related healthcare field.
Experience in Clinical Research, Clinical Monitoring, or Clinical Operations is preferred.
Good understanding of Phase I–IV clinical trials, ICH-GCP, and regulatory guidelines.
Strong analytical, documentation, and communication skills.
Experience
Preferred Experience: 3–5 years of experience in Clinical Monitoring, CRA, Central Monitoring, Clinical Operations, or Clinical Quality Review.
Salary Package (Estimated Market Standard)
₹8 LPA – ₹12 LPA (depending on clinical research experience, monitoring expertise, and interview performance).
Work Mode
Pune Location
Work mode as per company/project requirements
Why Join Syneos Health?
Opportunity to work on global Phase I–IV clinical trials.
Exposure to international sponsors and regulatory standards.
Career growth through structured learning and technical development.
Collaborative and inclusive work culture.
Employee recognition and performance-based rewards.
Opportunity to contribute to patient safety and clinical research quality.
About Syneos Health
Syneos Health is a leading global life sciences organization that partners with pharmaceutical, biotechnology, and healthcare companies throughout the drug development and commercialization lifecycle. Over the past five years, the company has contributed to 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and supported 200+ clinical studies across 73,000 sites involving more than 675,000 clinical trial participants.
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