Clinical Trial Manager, FSP

Thermo Fisher Scientific

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

Posted 10/31/2026full-timeRemote • BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 resource allocation to meet study timelines and regulatory requirements.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceClinical Monitoring PracticesBudgeting And Fiscal ManagementLeadership And Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Quality Plan DevelopmentCRF DesignRegulatory SubmissionsMonitoring Plan DevelopmentProject Financial ManagementTimelines And Metrics MonitoringDocument Quality AssuranceEthics Committee CoordinationAutomated Systems Proficiency

Soft Skills

LeadershipProblem-SolvingInterpersonal SkillsOrganizational SkillsDecision-Making

Tools & Technologies

OutlookExcelWord

Industry Keywords

Clinical OperationsRegulatory ComplianceClinical TrialsStudy Start-Up ActivitiesInformed Consent Templates

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 the Data Quality Plan and Master Action Plan
Ensure timely setup, organization, content, and quality of relevant Trial Master File sections
Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents
Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings
Collaborate with clinical and cross-functional teams, 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 activity timelines and metrics, provide status updates, review projects, 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 protocol, patient participation, case report forms, and study-related 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, assign and delegate 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 previous experience providing the knowledge, skills, and abilities to perform the job
Equivalent combination of appropriate education, training, and/or directly related experience may be considered
English language proficiency
Familiarity with clinical monitoring practices, processes, and requirements
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
Good computer skills, including Outlook, Excel, Word, and automated systems
Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making 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
Knowledge of budgeting, forecasting, and fiscal management
Strong attention to detail
Willingness and ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

Fully remote work mode
Standard Monday–Friday work schedule
Collaboration and professional development opportunities
Mentoring and training environment
Global team environment
Exposure to scientific innovation and excellence