Central Review Manager

🔥 0 minutes ago

🌐 Mexico, Brazil – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Perform centralized report review and approval of PSA, SI IMV, and CO reports on assigned projects in accordance with procedural documents and guidelines • Review clinical monitoring visit reports for allocated projects, ensuring consistency across protocols and/or regions, and escalate protocol, site, CRA issues or trends to CL • Liaise with clinical monitoring staff for prompt trip report review submission and approval according to CRG and/or Sponsor timelines • Participate actively on project teams to help ensure compliance with monitoring visit report expectations • Review and customize Monitoring Report Templates for allocated projects • Evaluate PI oversight, subject safety, and study processes to assess site capability • Attend applicable internal Project meetings • Provide input of forecast estimates for report review activities • Track trial MVR status and provide progress updates to the team • Contribute to company, client, and federal/local regulatory requirements and audit responses • Perform agreed support activities for allocated projects

🎯 Requirements

• Bachelor’s Degree in a life 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 • Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA • Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and CRG procedural documents • Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) • Highly effective oral and written communication skills with the ability to communicate effectively with project team members • Excellent organizational and time management skills • Ability to work in a team or independently or as home based, as required • 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 • Ability to mentor junior team members, as needed

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