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 trials with a strong focus on compliance with ICH GCP and FDA guidelines, while effectively leading teams and coordinating project deliverables. Proficient in clinical monitoring practices, financial management, and developing essential clinical documentation.

Highest-signal resume keywords

Clinical Trial OperationsICH/GCP ComplianceProject ManagementFinancial AcumenLeadership and Team Motivation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringStudy ManagementRegulatory SubmissionsCRF DevelopmentMonitoring PlansData Quality PlanTrial Master File ManagementBudgeting and ForecastingRisk ManagementClinical Resource Management

Soft Skills

LeadershipProblem-SolvingCommunicationAttention to DetailInterpersonal Skills

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical ResearchHealthcareTherapeutic Area KnowledgePatient CareClinical Expertise

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 regional Lead CTM, Clinical Study Manager, process improvement, complex program management, management, or project coordination responsibilities as needed
Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan
Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections
Participate in developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
Collaborate with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborate with clinical teams and other departments to meet project deliverables
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train standardized clinical monitoring processes
Ensure timely archiving of documents and study materials
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects using tracking and management tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
Monitor clinical trials, assess performance, and ensure contractual obligations are met
Conduct Accompanied Field Visits and manage project financials as needed
Communicate with study sites about protocols, patient participation, case report forms, and other study issues
Coordinate study start-up activities and ensure essential document quality meets Regulatory Compliance Review expectations
Ensure timely regulatory submissions and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, delegate clinical responsibilities, and identify 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, team motivation, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills
Strong understanding of change management principles and clinical monitoring practices, processes, and requirements
Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management
In-depth understanding of relevant regulations such as ICH/GCP and FDA guidelines
Strong computer skills, including Outlook, Excel, Word, and computerized applications
Ability to independently manage clinical-only studies
English language proficiency

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Scientific excellence-focused work environment
Frequently drives to site locations and frequently travels both domestic and international