Sr Central Review Manager

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.
• Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor.
• Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Reviews and customizes the Monitoring Report Templates for allocated projects.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
• Attends applicable internal Project meetings.
• Provides input of forecast estimates for report review activities.
• Provides trial MVR status tracking and progress update reports to team as required.
• Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.
• May perform support activities to the team as agreed on allocated projects.

• Bachelor’s Degree in a life science-related
• 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 PPD 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
• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.