Job Description: Clinical Monitoring Report (MVR) Specialist
Work Schedule
Type: Standard (Mon-Fri)
Environmental Conditions: Office-based
Purpose
At Thermo Fisher Scientific, we are committed to advancing science and healthcare across the globe. As part of our mission, we are looking for a Clinical Monitoring Report (MVR) Specialist to contribute to high-quality clinical trials. Your role will focus on the review and oversight of clinical monitoring visit reports (MVR) and contribute to clinical operations across multiple projects, ensuring compliance with study protocols, regulatory requirements, and quality standards.
Key Responsibilities
Clinical Monitoring Report Review:
Review clinical monitoring visit reports (MVR) to ensure consistency with protocols and across regions.
Escalate any issues related to protocol adherence, site performance, or clinical research associate (CRA) observations to the Clinical Trial Manager (CTM).
Provide input to customize monitoring report templates for allocated projects.
Project Coordination and Team Support:
Work closely with clinical monitoring staff to ensure timely submission and approval of trip reports in alignment with stipulated timelines.
Contribute to project meetings and support the project team to ensure monitoring visit report expectations are met.
Track and report MVR status to the team, providing progress updates as needed.
Trial Assessment and Documentation:
Evaluate Principal Investigator (PI) oversight, subject safety, and study processes from monitoring visit reports to assess a site’s ability to conduct studies.
Contribute to the development of reports in response to regulatory requirements or audits.
Forecasting and Risk Assessment:
Provide estimates for report review activities and evaluate risks at the site level by interpreting data from various sources, including protocols and electronic study data systems.
Mentorship and Support:
Offer mentorship and guidance to junior team members as needed.
Education and Experience
Bachelor’s degree in a life science-related field.
Minimum of 2 years of clinical research experience, with at least 1 year focused on clinical site monitoring.
Knowledge, Skills, and Abilities
Strong therapeutic area knowledge and understanding of medical terminology.
Familiarity with FDA, local regulations, ICH GCPs, and PPD procedural documents.
Ability to complete PPD’s Clinical Foundation Training Program (CFP) successfully.
Excellent communication skills (both oral and written), with the ability to effectively communicate with project team members.
Strong organizational and time management skills.
Ability to work both independently and in a team environment.
Expertise in writing and reviewing clinical monitoring visit reports, interpreting data, and assessing site-level risks.
Mentorship skills for junior team members.
Why Thermo Fisher Scientific?
By joining Thermo Fisher Scientific, you will become part of a global team committed to enabling customers to make the world healthier, cleaner, and safer. We are an organization that values diversity, and we work together to overcome scientific challenges, drive innovation, and improve health outcomes worldwide.
For more information and to apply, visit Thermo Fisher Careers.
Equal Opportunity Employer: Thermo Fisher Scientific is committed to diversity and inclusion. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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