Central Review Manager, Senior

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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