Thermo Fisher Scientific · 4 hours ago
Senior Clinical Trial Manager, FSP
North Carolina, United States
Full-time
Hybrid
Senior Level
5+ years expThermo Fisher Scientific is committed to making a positive impact on global health through innovative clinical research. The Senior Clinical Trial Manager is responsible for overseeing clinical operations and ensuring the successful execution of clinical trials, managing teams, and maintaining 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 moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities
Ensure 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 (DM, Reg, CMC etc…): ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan
Support and ensure 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
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO
Develops clinical tools (e.g. Monitoring 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 required. 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 monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines
Provides 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
In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
Qualification
Required
Global CTM experience
Highly experienced in CRO and monitoring oversight
Strong vendor management skills
MUST HAVE previous experience in both on site monitoring & in a CTM role
Travel: 40-50% Travel; US Travel
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
Preferred
East Coast HIGHLY preferred
Therapeutic Indication: Rare Disease is HIGHLY preferred
Onsite Monitoring experience is also preferred
2+ Years of NEUROLOGY OR RARE DISEASE Experience is HIGHLY preferred
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
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
Genetic Engineering News
2026-01-16
Investor's Business Daily
2026-01-16
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