WFH Life Sciences Jobs at Thermo Fisher – BSc Apply Online
Sr Central Review Manager
Location: Remote, India
Job Id: R-01273936
Job Type: Full time
Category: Clinical Research
Remote: Fully Remote
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
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.A Day in the Life:
- 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 the 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 the 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.
Education
- Bachelor’s Degree in a life science-related field.
- Prior clinical research experience with a minimum of 2 years of on-site clinical monitoring.
Knowledge, Skills, Abilities
- Good therapeutic area knowledge and understanding of medical terminology by virtue of past training as a CRA.
- Ability to attain and maintain a working knowledge of FDA and/or local country regulations 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 the 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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