Thermo Fisher Scientific · 1 day ago
Clinical Team Manager/Sr. (CTM) - FSP
North Carolina, United States
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific is a global leader in scientific services, dedicated to making the world healthier, cleaner, and safer. The Clinical Team Manager/Sr. (CTM) is responsible for managing clinical deliverables, ensuring compliance with regulations, and overseeing the clinical team to meet customer expectations for quality and timelines.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
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 Biogen CSO (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
May include reginal coordination with regional CMLs
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
May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates
Generate monitoring plan and trip report completion annotations
Qualification
Required
Bachelor's degree and previous experience comparable to 5+ years
Monitoring or Study Management, and Oversight experience preferred
Extensive Neuroscience 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
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
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains
Preferred
Monitoring or Study Management, and Oversight experience preferred
Extensive Neuroscience experience preferred
Prior client-dedicated experience preferred
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2026-01-09
EIN Presswire
2026-01-07
Company data provided by crunchbase