Clinical Trial Manager

Thermo Fisher Scientific

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

Posted 10/22/2026full-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 developing clinical tools, monitoring clinical trials, and effectively communicating with study sites and project teams.

Highest-signal resume keywords

Clinical Monitoring PracticesICH/GCP ComplianceLeadership and Team MotivationBudgeting and Financial AcumenEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Quality Plans DevelopmentCRF CompletionProtocol DevelopmentStudy Start-Up CoordinationDocument Quality AssuranceMonitoring Visit Reports ReviewResource ManagementTimelines ManagementQuery Resolution

Soft Skills

Interpersonal SkillsProblem-Solving SkillsPlanning and Organizational SkillsJudgment and Decision-Making SkillsAdaptability in Changing Environments

Tools & Technologies

OutlookExcelWordAutomated SystemsComputerized Applications

Industry Keywords

Clinical OperationsQuality AssuranceRegulatory SubmissionsEthics Committee InteractionMulticultural Matrix Organization

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
Develop clinical tools and contribute to Data Quality Plans, Master Action Plans, Trial Master File organization, CRFs, informed consent templates, and protocol-specific documents
Collaborate with project managers, clinical teams, and other departments to prepare and present client meetings
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Ensure timely archiving of study documents and materials
Achieve final clinical deliverables within contractual timelines by monitoring clinical activity timelines and metrics, reviewing tracking tools and monitoring visit reports, implementing recovery actions, and managing CRF collection and query resolution
Monitor or co-monitor clinical trials and assess performance against contractual obligations
Communicate with study sites regarding protocol, patient participation, CRF completion, and other study issues
Coordinate study start-up activities and ethics committee and regulatory submissions
Ensure essential document quality and follow up on ethics committee questions
Provide input to 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 experience providing the knowledge, skills, and abilities to perform the job
Equivalency may consist of a combination of appropriate education, training and/or directly related experience
Leadership, mentoring, training, team motivation, and integration skills
Planning and organizational skills for workload prioritization
Interpersonal and problem-solving skills in a multicultural matrix organization
Ability to work effectively in changing environments with complex/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 budgets 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 other automated systems and computerized applications
Frequent domestic and international travel and driving to site locations

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Passion, innovation, and commitment to scientific excellence