Thermo Fisher Scientific · 1 day ago
Sr. Clinical Team Manager (CTM)/ Prin. - Neurology
North Carolina, United States
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expThermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. The Sr. Clinical Team Manager is responsible for managing clinical operational and quality aspects of studies, ensuring deliverables meet customer expectations while maintaining profitability and compliance with regulatory standards.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects
Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
May connect with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that crucial document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements
Qualification
Required
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)
Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Good planning and organizational skills to enable effective prioritization of workload
Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
Capable of working effectively in a changing environment with sophisticated/ambiguous situations
Familiarity with the practices, processes, and requirements of clinical monitoring
Good judgment and decision making skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating workload against project budget and adjusting resources accordingly
Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
Good digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
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
therapeutic indication experience: Ophthalmology, Rare Disease, Sleep, and/or Psychiatry (Ophthalmology specific: General ophthalmology, Diabetic Macular Edema & Geographic Atrophy)
3+ years of CTM experience (North America) + global gCTM experience +/- biotech experience
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
EIN Presswire
2026-01-07
EIN Presswire
2026-01-05
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