Clinical Team Manager – Neuro

Thermo Fisher Scientific

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

Posted 11/4/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial operations, including end-to-end study management, compliance with ICH GCP and FDA guidelines, and effective communication with study sites. Proficient in developing clinical tools and monitoring plans while leading teams to ensure quality and timely project execution.

Highest-signal resume keywords

Clinical Trial OperationsICH GCP ComplianceEnd-to-End Study ManagementClinical Monitoring PracticesLeadership and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementData Quality PlansMonitoring Plans DevelopmentCRF DesignProject Financial ManagementRegulatory SubmissionsClinical Activity ForecastingQuery ResolutionTimelines ManagementEthics Committee Coordination

Soft Skills

Problem-SolvingDecision-MakingInterpersonal SkillsAttention to DetailOrganizational Skills

Tools & Technologies

OutlookExcelWordTracking ToolsClinical Monitoring Software

Industry Keywords

Clinical ResearchTherapeutic Area KnowledgePatient Care ResponsibilitiesEarly Phase StudiesPsychiatryParkinson's DiseaseSleep DisordersEpilepsyHearing LossCAR-T Experience

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 Data Quality Plans and Master Action Plans
Establish, organize, maintain, and archive relevant local and central Trial Master File sections
Participate in designing CRFs, CRF guidelines, 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 teams and other departments; lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes and corporate policies
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects with tracking tools, and implement recovery actions
Review monitoring visit reports, manage CRF collection and query resolution, and monitor or co-monitor clinical trials
Conduct Accompanied Field Visits and manage project financials in smaller regions when required
Communicate with study sites regarding protocols, patient participation, case report forms, and related issues
Coordinate study start-up activities and timely ethics committee and regulatory submissions
Ensure essential document quality and follow up on ethics committee questions
Provide input into clinical activity forecasts and manage clinical resources, assignments, delegations, 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
Experience in end-to-end study management of studies
Early Phase and Start-up experience preferred
Familiarity with clinical monitoring practices, processes, and requirements
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
English language proficiency
Computer skills using Outlook, Excel, Word, and similar computerized applications
Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, communication, financial management, budgeting, forecasting, fiscal management, and attention-to-detail skills
Ability to work effectively in a changing environment with complex or ambiguous situations
Ability to evaluate workload against project budget and adjust resources accordingly
Therapeutic-area experience in psychiatry, Parkinson's disease, sleep disorders, epilepsy, hearing loss, or listed rare diseases; CAR-T experience is a plus

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Exposure to passion, innovation, and scientific excellence
Standard Monday-Friday work schedule