Central Review Manager (Senior)
On-siteMexico City, Mexico City, Mexico
Mexico City, Mexico City, MexicoOn-siteFull TimeSenior LevelBachelors DegreeLarge
Full TimeSenior LevelBachelors DegreeLarge
Job Summary
Review and approve centralized clinical monitoring visit reports for assigned projects, ensuring protocol consistency and escalating site or CRA issues to Clinical Leads. Liaise with clinical monitoring staff to meet submission timelines, customize report templates, and evaluate PI oversight and subject safety. Provide training and mentoring to new Central Review Managers, act as a lead reviewer on allocated projects, and serve as the central liaison between the CRM team and project leads. Track trial MER status and contribute to regulatory audit responses as required.
Required Qualifications
- 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 4 years on site clinical monitoring or minimum 5+ years report review experience
- 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
- Ability to successfully complete PPD's Clinical Foundation Training Program (CFP)
- 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 extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of all these data
- Excellent English language and grammar skills
- Excellent Leadership skills
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