Clinical Team Manager – FSP

Thermo Fisher Scientific

. Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP .

Posted 9/23/2026full-timeRemote • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical operational and quality aspects of studies, ensuring compliance with ICH GCP and FDA guidelines. Proficient in clinical monitoring practices, project management, and effective communication with cross-functional teams.

Highest-signal resume keywords

Clinical Study ManagementICH GCP ComplianceClinical Monitoring PracticesProject Financial ManagementEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementCRF DesignMonitoring Plan DevelopmentBudgeting and ForecastingTrial Master File ManagementRegulatory SubmissionsData Collection and Query ResolutionProject Timeline MonitoringEthics Committee CoordinationClinical Resource Management

Soft Skills

Leadership SkillsInterpersonal SkillsProblem-Solving SkillsOrganizational SkillsTeam Integration Skills

Tools & Technologies

OutlookExcelWordAutomated Systems

Industry Keywords

Clinical OperationsQuality AssuranceMulticultural Matrix OrganizationClinical Monitoring ProcessesFDA Guidelines

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
Assume Clinical Study Manager responsibilities on small or less complex projects when required
Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to the Master Action Plan
Set up, organize, maintain, and archive relevant Trial Master File sections and study materials
Participate in designing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
Collaborate with clinical and cross-functional teams and lead team meetings
Implement and train teams on standardized clinical monitoring processes
Prepare and monitor clinical activity timelines and metrics, provide project status updates, and implement recovery actions
Review monitoring visit reports and manage CRF collection and query resolution
Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
Conduct Accompanied Field Visits and manage project financials in smaller regions when required
Communicate with study sites regarding protocol, patient participation, CRF completion, and related issues
Coordinate study start-up activities and ethics committee and regulatory submissions when required
Review and follow up on ethics committee questions
Provide input into clinical activity forecasts and manage clinical resources, delegation, and additional resource requirements

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of previous comparable experience
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Leadership, mentoring, training, motivation, and team integration skills
Planning and organizational skills
Interpersonal and problem-solving skills in a multicultural matrix organization
Ability to work effectively in changing environments with complex or ambiguous situations
Familiarity with clinical monitoring practices, processes, and requirements
Judgment and decision-making skills
Effective oral and written communication skills, including English language proficiency
Ability to evaluate workload against project budget and adjust resources
Financial acumen and knowledge of budgeting, forecasting, and fiscal management
Strong attention to detail
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
Computer skills using Outlook, Excel, Word, and similar automated systems
Frequent domestic and international travel and driving to site locations

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Scientific excellence-focused workplace