Clinical Team Manager – Internal Medicine

Thermo Fisher Scientific

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

Posted 10/30/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial operations, including compliance with ICH GCP and FDA guidelines, while effectively leading teams and coordinating resources to ensure successful study execution and quality outcomes.

Highest-signal resume keywords

Clinical Trial OperationsICH/GCP ComplianceProject ManagementLeadership and MentoringClinical Monitoring Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementData Quality PlansMonitoring PlansTrial Master File ManagementCRF DevelopmentRegulatory SubmissionsBudgeting and ForecastingClinical Resource ManagementChange Management PrinciplesPatient Care Responsibilities

Soft Skills

LeadershipCommunicationProblem-SolvingAttention to DetailDecision-Making

Tools & Technologies

OutlookExcelWordAutomated SystemsComputerized Applications

Industry Keywords

Clinical ResearchHealthcareNursingTherapeutic Area KnowledgeClinical Monitoring

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP
Assume Lead CTM, regional Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as needed
Develop clinical tools, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, Master Action Plans, Trial Master File sections, CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Lead clinical team meetings and coordinate teams and departments to maintain timelines, resources, interactions, and quality
Implement and train standardized clinical monitoring processes
Ensure timely archiving of study documents and materials
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution
Monitor clinical trials to assess performance and meet contractual obligations
Conduct Accompanied Field Visits and manage project financials as needed
Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues
Coordinate study start-up activities and regulatory submissions, and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, assignment, delegation, and additional resource requirements

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities
Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities
An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, financial, attention-to-detail, and communication skills
English language proficiency
Strong understanding of change management principles and clinical monitoring practices, processes, and requirements
Knowledge of budgeting, forecasting, and fiscal management
In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines
Strong computer skills, including Outlook, Excel, Word, automated systems, and computerized applications
Ability to independently manage clinical-only studies
Ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

Collaboration and development opportunities
Global team environment
Frequent domestic and international travel opportunities