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Clinical Team Manager – Senior, FSP
Thermo Fisher ScientificClinical Team Manager managing clean data deliverables for clinical trials at Thermo Fisher Scientific. Ensuring compliance and quality while collaborating with clinical teams and clients.
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
- Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations
- Develops clinical tools and study plans, collaborates with client (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality
- Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
- Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management
- Completes trip report reviews in compliance with study plan timeline
- Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis
Requirements
What you’ll need- Bachelor's degree
- previous experience comparable to 5+ years
- Monitoring, Study Management or Oversight experience preferred
- Prior client-dedicated experience preferred
- 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
- 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- competitive remuneration
- annual incentive plan bonus
- healthcare
- a range of employee benefits
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 trials monitoringdata entrytrend analysisstudy managementregulatory complianceprotocol developmentresource managementdata interpretationquality assuranceSOPs
Soft Skills
mentoringleadershipsupervisory skillsorganizational skillsnegotiation skillsattention to detailwritten communicationoral communicationteam buildingconflict resolution
Certifications
Bachelor's degree