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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.
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operational managementquality managementmonitoring plan developmentdata quality planningtrial master file managementclinical activity timeline preparationmetrics monitoring
Soft Skills
collaborationcommunicationorganizationleadershippresentation skills
Certifications
Bachelor's degreeformal academic qualificationvocational qualification