Central Review Manager, Senior
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Job Description
Senior Central Review Manager ensuring operational excellence in centralized report reviews at Thermo Fisher Scientific. Collaborate and mentor within a global clinical research team.
Responsibilities:
- Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions
- Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor
- Reviews and customizes the Monitoring Report Templates for allocated projects
- Evaluates PI oversight, subject safety and study processes to assess site’s ability to conduct study
- Attends applicable internal Project meetings
- Provides input of forecast estimates for report review activities
- Provides trial MVR status tracking and progress update reports to CTM/CRA
- Contributes to company, client, and federal/local regulatory requirements/audit responses
- Provides training and mentoring to new CRMs
- May act as lead report reviewer on allocated projects
Requirements:
- Bachelor’s Degree in a science-related field or relevant/equivalent combination of education, training, and experience
- Prior clinical research experience with a minimum of 2 years on site clinical monitoring
- Excellent therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents
- Highly effective oral and written communication skills
- Excellent organizational and time management skills
- Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports
- Ability to mentor junior team members
Benefits:
- Health insurance
- 401(k)
- Flexible work arrangements
- Professional development
- Paid time off
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