Central Review Manager
Company: PPD / Thermo Fisher Scientific
Job ID: R-01363303
Employment Type: Full-Time
Work Arrangement: Fully Remote
Work Schedule: Second Shift (Afternoons)
Category: Clinical Research
Function: Clinical Research / Centralized Monitoring
Position Overview
The Central Review Manager is responsible for centralized review and approval of clinical monitoring visit reports across assigned clinical research projects.
The role focuses on reviewing Pre-Study Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close-Out Visit (COV) reports to ensure consistency, quality, compliance, and alignment with study protocols, regulatory requirements, and company procedures.
The Central Review Manager works closely with Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), monitoring teams, and project stakeholders to identify site-level risks, trends, protocol issues, and data inconsistencies.
Key Responsibilities
Centralized Monitoring Report Review
Perform centralized review and approval of PSV, SIV, IMV, and COV reports for assigned clinical trials.
Review clinical monitoring visit reports for completeness, accuracy, consistency, and compliance.
Ensure consistency in monitoring reports across different protocols, sites, and regions.
Identify and escalate protocol issues, site concerns, CRA issues, and emerging trends to the Clinical Trial Manager.
Review information captured in monitoring reports and associated electronic study systems.
Assess whether reports meet PPD and sponsor expectations.
Site and Study Risk Assessment
Evaluate Principal Investigator (PI) oversight and protocol adherence.
Review subject safety information captured within monitoring reports.
Assess study processes and site performance.
Evaluate the site's ability to conduct the clinical trial based on monitoring visit information and electronic study data.
Identify potential site-level risks and trends.
Extract relevant information from protocols, CTMS, dashboards, and electronic study systems to support risk assessment.
Use available study data to identify inconsistencies, compliance concerns, and areas requiring further attention.
Monitoring Report Management
Review and customize Monitoring Report Templates for assigned projects.
Liaise with clinical monitoring staff to ensure timely submission of monitoring visit reports.
Follow up with CRAs and monitoring staff regarding report review comments and approvals.
Ensure monitoring reports are reviewed and approved within required PPD and sponsor timelines.
Track monitoring visit report status and provide progress updates to project teams.
Maintain accurate documentation of report review activities.
Project Team Collaboration
Actively participate in assigned project teams.
Attend applicable internal project meetings.
Communicate monitoring report findings and relevant trends to CTMs and project stakeholders.
Work collaboratively with clinical monitoring teams to resolve report-related issues.
Support compliance with monitoring visit report requirements throughout the study.
Provide support activities to project teams as agreed upon.
Forecasting and Reporting
Provide input into forecast estimates for monitoring report review activities.
Track workload, report volumes, review status, and project progress.
Prepare monitoring visit report status and progress reports as required.
Communicate potential delays, risks, or resource requirements to appropriate stakeholders.
Quality, Compliance, and Regulatory Support
Ensure review activities comply with applicable PPD procedures and project-specific requirements.
Maintain working knowledge of FDA and/or applicable local country regulations and guidelines.
Apply ICH Good Clinical Practice (ICH-GCP) principles to assigned activities.
Support company, client, and regulatory audit responses when required.
Contribute to regulatory inspection and audit readiness activities.
Identify and escalate compliance concerns appropriately.
Mentoring and Team Support
Provide guidance and support to junior team members when required.
Share knowledge and best practices related to clinical monitoring report review.
Support team members in interpreting monitoring reports and identifying relevant study risks.
Contribute to continuous improvement of centralized review processes.
Required Education and Experience
Bachelor's degree in a life sciences-related field.
Equivalent combinations of education, training, and relevant experience may also be considered.
Minimum 2 years of prior clinical monitoring experience at clinical sites.
Previous Clinical Research Associate (CRA) experience is highly relevant.
Experience writing, reviewing, or approving clinical monitoring visit reports.
Required Knowledge and Skills
Good knowledge of relevant therapeutic areas.
Strong understanding of medical terminology.
Practical understanding of clinical trial processes.
Knowledge of FDA and/or applicable local regulatory requirements.
Knowledge of ICH-GCP guidelines.
Understanding of PPD procedural documents and clinical research processes.
Ability to interpret clinical monitoring visit reports.
Ability to identify relevant information and assess site-level risk.
Experience working with:
Clinical Trial Management Systems (CTMS)
Electronic study data systems
Study dashboards
Clinical trial protocols
Excellent written and verbal English communication skills.
Strong English grammar and report-writing skills.
Excellent organizational and time-management abilities.
Strong attention to detail.
Ability to work independently and collaboratively.
Ability to work effectively in a fully remote environment.
Ability to successfully complete the required Clinical Foundation Training Program (CFP).
Ideal Candidate Profile
The ideal candidate is an experienced CRA or clinical research professional who has strong experience with clinical monitoring and monitoring visit reports.
Candidates should be comfortable reviewing large amounts of clinical information, identifying site-level risks, assessing protocol compliance, and communicating findings to CTMs and project teams.
Strong report-writing, analytical, organizational, and communication skills are essential for success in this role.
Work Environment
Fully remote position.
Second-shift working schedule.
Work primarily involves computer-based clinical research activities.
Regular interaction with global project teams and clinical monitoring personnel.
Exposure to standard electrical office equipment.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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