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Senior Clinical Trial Manager – Non-Interventional Studies
Thermo Fisher ScientificSenior Clinical Trial Manager responsible for clinical deliverables in non-interventional studies at Thermo Fisher. Managing project timelines and collaborating with teams to ensure quality outcomes.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
clinical operational managementquality managementmonitoring plan developmentdata quality planningtrial master file managementclinical activity timeline preparationmetrics monitoring
Soft Skills
collaborationcommunicationorganizationleadershippresentation skills
Certifications & Qualifications
Bachelor's degreeformal academic qualificationvocational qualification
Industry Keywords
ICH GCPnon-interventional studiesPhase IV studiesreal-world evidence (RWE)STM role
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
- Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Regularly communicate with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics.
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies.
Benefits
Comp & perks- Competitive salary
- Flexible working hours