Clinical Team Manager – HemOnc

Thermo Fisher Scientific

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

Posted 9/18/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial operations, ensuring compliance with ICH GCP and FDA regulations, while effectively leading cross-functional teams and maintaining project timelines and quality. Proficient in developing clinical tools and monitoring plans, with a strong background in therapeutic areas and direct patient care.

Highest-signal resume keywords

Clinical Trial OperationsICH GCP ComplianceGlobal CTM ExperienceClinical MonitoringProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchStudy ManagementData Quality PlansCRF DesignRegulatory SubmissionsMonitoring PlansTrial Master File ManagementBudgetingForecastingResource Management

Soft Skills

Effective CommunicationLeadershipProblem-SolvingOrganizational SkillsAttention to Detail

Tools & Technologies

OutlookExcelWordTracking Tools

Industry Keywords

Clinical MonitoringHealthcareTherapeutic Area KnowledgePatient CareFSO/CRO ExperienceOvarian CancerSickle Cell DiseaseNon-Hodgkins LymphomaCell and Gene TherapyCART-T

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, monitoring plans, monitoring guidelines, data quality plans, and clinical sections of the Master Action Plan
Ensure timely setup, organization, content, and quality of local and central Trial Master File sections
Participate in designing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Collaborate with clinical and cross-functional teams to meet project deliverables
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on 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 tools, 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 protocols, patient participation, case report forms, and other study issues
Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions
Ensure essential document quality meets Regulatory Compliance Review expectations 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
Must have FSO/CRO experience
Must have Global CTM experience managing global teams
Indication experience in one or more of: Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T
Familiarity with the practices, processes, and requirements of clinical monitoring
Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines
Good computer skills using Outlook, Excel, Word, and similar computerized applications
Effective oral and written communication skills, including English language proficiency
Good leadership, planning, organizational, interpersonal, problem-solving, judgment, decision-making, financial, budgeting, forecasting, fiscal management, and attention-to-detail skills
Capable of working effectively in a changing environment with complex or ambiguous situations
Capable of evaluating workload against project budget and adjusting resources accordingly

Benefits

Comp & perks

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