Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Central Review Manager – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our general team, you’ll have the opportunity to perform centralized report review and approval of PSA, SI, ME, and CO reports on assigned projects in accordance with procedural documents and guidelines.
What You’ll Do:
• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CL.
• Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of CRG and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Reviews and customizes the Monitoring Report Templates for allocated projects.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
• Attends applicable internal Project meetings.
• Provides input of forecast estimates for report review activities.
• Provides trial MER status tracking and progress update reports to team as required.
• Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.
• May perform support activities to the team as agreed on allocated projects.
Education and Experience Requirements:
• Bachelor’s Degree in a life science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowle
📌 Central Review Manager (Ciudad de México)
🏢 Thermo Fisher Scientific
📍 Ciudad de México
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