Central Review Manager

Thermo Fisher Scientific · Karnātaka, India

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Role summary

Thermo Fisher Scientific seeks a Central Review Manager to oversee clinical monitoring visit report reviews and approvals across multiple projects. The role involves coordinating with clinical teams, ensuring protocol compliance, and supporting regulatory requirements in a second-shift office position based in Bangalore.

What they're looking for

Bachelor's degree in life science field or equivalent education and experience
Minimum 2 years on-site clinical monitoring experience
Knowledge of FDA, ICH GCP, and local regulatory guidelines
Strong written and oral communication skills with clinical terminology fluency
Ability to complete Clinical Foundation Training Program (CFP)
Proficiency in extracting and interpreting clinical data from protocols and electronic systems
Excellent English language skills and organizational abilities

What you'll be doing

Review clinical monitoring visit reports for consistency across protocols and regions, escalating issues to CTM
Liaison with clinical monitoring staff to ensure timely report submission and approval per sponsor requirements
Customize monitoring report templates and evaluate site capability for study conduct
Track monitoring visit report status and provide progress updates to project team
Attend project meetings and contribute to regulatory audit responses and compliance activities

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Date posted10 days ago

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