Central Review Manager Job in Bangalore at Thermo Fisher Scientific

Thermo Fisher Scientific is hiring for the role of Central Review Manager!

Responsibilities of the Candidate:

• Perform review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalate any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.
• Liaise with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Review and customize the Monitoring Report Templates for allocated projects.
• Evaluate PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess the site’s ability to conduct the study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
• Attend applicable internal Project meetings.
• Provide input of forecast estimates for report review activities.
• Provide trial MVR status tracking and progress update reports to team as required.
• Contribute to company, client, and federal/local regulatory requirements/audit responses as needed.
• Perform support activities to the team as agreed on allocated projects.