Syneos Health is recruiting for the position of Central Report Reviewer for a remote role in India. The position involves reviewing clinical monitoring reports and documentation to ensure compliance with clinical trial protocols, Good Clinical Practice (GCP), regulatory requirements, patient safety standards, and data integrity expectations.
Candidates with a relevant bachelor’s degree or RN qualification, clinical trial experience, and knowledge of ICH GCP guidelines can review the eligibility requirements and apply through the official Syneos Health careers portal.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Job Title | Central Report Reviewer |
| Job Requisition ID | 25109862 |
| Location | India – Remote |
| Work Mode | Remote (Pre-Approved) |
| Employment Type | Full-time |
| Qualification | Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience |
| Application Mode | Online |
Position
Central Report Reviewer
The role focuses on reviewing site and central monitoring documentation, identifying risks related to patient safety and clinical data integrity, documenting review observations, and supporting clinical trial compliance and study management activities.
Responsibilities
- Review clinical monitoring documentation according to the study monitoring strategy, focusing on patient safety, protocol compliance, GCP, regulatory requirements, and data integrity.
- Support the development of annotated visit reports, including PSV, SIV, IMV, COV, and SCAN reports.
- Review site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence.
- Document requested revisions and approvals in the Clinical Trial Management System (CTMS).
- Ensure deliverables meet company or sponsor specifications and deadlines.
- Identify issues affecting patient safety and clinical data integrity, including protocol deviations, violations, sponsor-specific requirements, and pharmacovigilance issues.
- Escalate serious issues immediately to the Clinical Trial Manager (CTM) or Project Manager.
- Document review observations and ensure protocol deviations and action items are recorded in appropriate systems.
- Assess CRA/CM report quality, risks, trends, and operational performance where required.
- Participate in clinical monitoring meetings, project discussions, and clinical training sessions.
- Support CTM activities, including protocol deviation management and action-item management.
Eligibility and Qualifications
Candidates applying for the Syneos Health Central Report Reviewer position should have:
- A bachelor’s degree or RN qualification in a related field, or an equivalent combination of education, training, and experience.
- Previous clinical trial experience in site management and clinical activities is preferred.
- Experience in study management, such as working as a Lead CRA or in an equivalent role, is preferred.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements.
- The ability to work in an international environment.
Required Skills
- Clinical monitoring report review
- Clinical trial documentation and site management
- GCP and ICH guideline compliance
- Protocol deviation and risk identification
- Patient safety and clinical data integrity
- CTMS documentation and approval workflows
- Attention to detail and good documentation practices
- Critical thinking and problem-solving
- Computer skills and ability to learn new technologies
- Communication and interpersonal skills
- Cross-functional collaboration and issue escalation
Application Details
