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 10/28/2026full-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 developing clinical tools, coordinating teams, and maintaining project timelines and budgets.

Highest-signal resume keywords

Clinical Operational ManagementICH GCP ComplianceFinancial AcumenTeam LeadershipClinical Monitoring Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Quality PlansTrial Master File ManagementCRF DesignProject Budget EvaluationRegulatory SubmissionsMonitoring Visit Reports ReviewClinical Resource ManagementEthics Committee CoordinationClinical Metrics Monitoring

Soft Skills

Leadership SkillsInterpersonal SkillsProblem-Solving SkillsPlanning SkillsOrganizational Skills

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft Word

Industry Keywords

Clinical MonitoringMulticultural Matrix OrganizationBudgetingForecastingFiscal Management

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 Data Quality Plans and Master Action Plans
Set up, organize, maintain, and archive relevant Trial Master File sections and study materials
Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers on client meetings, bid defenses, and hand-off meetings
Coordinate clinical teams and departments, lead team meetings, and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
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/co-monitor clinical trials
Conduct Accompanied Field Visits and manage project financials in smaller regions when applicable
Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues
Coordinate study start-up activities and ethics committee and regulatory submissions when applicable
Review and follow up on ethics committee questions
Contribute to clinical activity forecasts and manage clinical resources, assignments, delegations, and additional resource needs

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of comparable experience
Equivalency may consist of appropriate education, training and/or directly related experience
Leadership, mentoring, training, motivation, and team integration skills
Planning and organizational skills
Interpersonal and problem-solving skills in a multicultural matrix organization
Familiarity with clinical monitoring practices, processes, and requirements
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
Computer skills with Outlook, Excel, Word, and similar applications
Ability to work in changing environments with complex/ambiguous situations

Benefits

Comp & perks

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