Clinical Team Manager – FSP

Thermo Fisher Scientific

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

Posted 9/15/2026full-timeRemote • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing clinical operational and quality aspects of studies, ensuring compliance with ICH GCP and FDA guidelines. Proficient in clinical monitoring practices, project management, and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Trial ManagementICH/GCP ComplianceProject Financial ManagementCRF Design and DevelopmentLeadership and Team Integration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Monitoring PracticesData Quality Plan DevelopmentTrial Master File ManagementBudgeting and ForecastingRegulatory SubmissionsCRF GuidelinesProtocol DevelopmentMetrics MonitoringDocument ArchivingField Visit Management

Soft Skills

LeadershipProblem-SolvingInterpersonal SkillsOrganizational SkillsEffective Communication

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical Research AssociateAlzheimer's ExperienceNeurology ExperienceEthics Committee InteractionStudy Start-Up Activities

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 the Data Quality Plan and Master Action Plan
Ensure timely setup, organization, content, and quality of 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 at client, bid defense, and hand-off meetings
Collaborate with clinical teams and departments to meet project deliverables
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Archive study documents and materials in a timely manner
Prepare and monitor clinical timelines and metrics, provide project status updates, and implement recovery actions
Review monitoring visit reports, manage CRF collection and query resolution, and monitor clinical trial performance
Conduct Accompanied Field Visits and manage project financials where applicable
Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues
Coordinate study start-up activities and ethics committee and regulatory submissions where applicable
Ensure essential document quality and follow up on ethics committee questions
Contribute to clinical activity forecasts and manage clinical resources, responsibilities, delegations, and additional resource needs

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience comparable to 5+ years
An equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient
Prior CRA experience preferred by the team
Alzheimer's and/or Neurology experience preferred by the team
Good leadership, mentoring, training, motivation, and team integration skills
Good planning and organizational skills
Solid interpersonal and problem-solving skills
Ability to work effectively in changing environments with complex/ambiguous situations
Familiarity with clinical monitoring practices, processes, and requirements
Good judgment and decision-making skills
Effective oral and written communication skills, including English language proficiency
Ability to evaluate workload against project budget 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
Good computer skills with Outlook, Excel, Word, and computerized applications

Benefits

Comp & perks

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