Thermo Fisher Scientific · 2 hours ago
Clinical Study Manager, FSP - IVD Experience Required
North Carolina, United States
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Clinical Study Manager with IVD experience. The role involves managing clinical operational and quality aspects of allocated studies, ensuring deliverables meet customer expectations, and collaborating with teams to achieve project goals.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
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
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
Communicates 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 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
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)
Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916
Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
Solid understanding of change management principles
Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
Strong judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills, including English language proficiency
Capable of evaluating own and team members workload against project budget and adjust resources accordingly
Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc
Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
Capable of independently managing clinical only studies
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
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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