Central Report Reviewer

Syneos Health, Inc.

Job Overview

Location

IND-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Central Report Reviewer role focuses on executing central monitoring activities for clinical studies, ensuring patient safety, protocol compliance, and data integrity.
• Review and assess site and central monitoring documentation, including site monitoring calls, visit reports, letters, and central monitoring reports, to confirm accurate representation of site management activities.
• Identify and document risks related to protocol/GCP compliance, trial conduct, patient safety, or data integrity, and record requested revisions and approvals in the Clinical Trial Management System (CTMS).
• Escalate serious issues promptly to Clinical Trial Manager or Project Manager, ensuring timely resolution and mitigation of potential safety or data concerns.
• Document observations from reviews and ensure protocol deviations or action items are captured in appropriate systems for follow‑up by CRAs, CMs, or other functional team members.
• Evaluate CRA/CM report quality, risk trends, and operational performance, summarizing findings for CTM review and action planning.
• Participate in clinical monitoring and project staff meetings, attend training sessions, and maintain up‑to‑date project status through regular discussion and email correspondence.
• Demonstrate understanding of cross‑functional roles in achieving compliance and delivery according to SOPs, ICH GCP, and country regulations.
• Support CTM activities such as Protocol Deviation management and Action Items management as needed.
• Apply knowledge of Good Clinical Practice, ICH Guidelines, and regulatory requirements to all monitoring tasks.
• Maintain strong documentation habits, attention to detail, and effective communication with project teams and sites.
• Utilize computer skills and adapt to new technologies to support monitoring workflows.
• Collaborate with international teams, ensuring cultural competence and effective communication across diverse environments.
• Leverage critical thinking and problem‑solving techniques to identify root causes and develop appropriate solutions for monitoring issues.
• Contribute to a culture of continuous improvement, sharing insights and best practices to enhance monitoring effectiveness.
• Align with Syneos Health’s mission of accelerating customer success and delivering impactful healthcare solutions.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Previous clinical trial experience in site management and clinical preferred
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong documentation habits, attention to detail, and good computer skills
• Excellent communication and interpersonal skills with project teams and sites

🏖️ Benefits

• Career development and progression opportunities
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture that values authenticity
• Access to a global network of 25,000 colleagues

Skills & Technologies

GCP

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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