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Senior Clinical Trial Manager – FSP
Thermo Fisher ScientificClinical Trial Manager overseeing complex clinical studies for Thermo Fisher Scientific. Ensuring compliance and meeting clinical deliverables within contractual timelines.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer.
- Interprets data on complex issues and makes good business decisions with support from line management.
- Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations.
- Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
- Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
- Ensures efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up.
- Supports and ensures that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
- Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Requirements
What you’ll need- Bachelor's degree
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 1+ year of leadership responsibility
- Previous On-Site Monitoring Experience
- Advanced mentoring/leadership/supervisory skills
- Excellent clinical trials monitoring skills; ideally remote AND onsite experience
- Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations(e.g. ICH/GCP, FDA guidelines)
- Strong organizational and negotiation skills
- Strong attention to detail
- Advanced written and oral communication skills
- Strong knowledge of English language and grammar
- Demonstrated use of computer to include data entry, archival and retrieval
- Ability to travel as needed
- Excellent team player with team building skills
- Excellent interpersonal and conflict resolution skills
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
Benefits
Comp & perks- Health insurance
- Professional development opportunities
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 deliverablesdata interpretationclinical trials monitoringEDC system tasksSOPsWPDsICH GCPFDA guidelinesdata entrymedical terminology
Soft Skills
leadershipmentoringsupervisory skillsorganizational skillsnegotiation skillsattention to detailwritten communicationoral communicationteam buildingconflict resolution
Certifications
Bachelor's degree