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 10/25/2026full-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, monitoring plans, and coordinating study activities while leading teams and managing project financials.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceClinical Monitoring PracticesProject Financial ManagementLeadership and Training

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData Quality PlansTrial Master File ManagementCRF DesignProject Status UpdatesMonitoring Guidelines DevelopmentEthics Committee SubmissionsRegulatory SubmissionsBudgetingForecasting

Soft Skills

LeadershipMentoringProblem-SolvingCommunicationAttention to Detail

Tools & Technologies

OutlookExcelWord

Industry Keywords

Clinical TrialsStudy Start-Up ActivitiesPatient ParticipationMulticultural Matrix OrganizationsAccompanied Field Visits

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, Data Quality Plans, and contribute to Master Action Plans
Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials
Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Lead clinical team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review 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 protocol, patient participation, case report forms, and other study issues
Coordinate study start-up activities and ethics committee and regulatory submissions when appropriate
Ensure essential document quality and follow up on ethics committee questions
Provide input into clinical activity forecasts and manage clinical resources, assignments, delegation, and 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
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Knowledge of clinical monitoring practices, processes, and requirements
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
English language proficiency
Good computer skills, including Outlook, Excel, and Word
Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, communication, financial management, budgeting, forecasting, and attention-to-detail skills
Ability to work effectively in a changing environment with complex/ambiguous situations and multicultural matrix organizations
Ability to evaluate workload against project budget and adjust resources accordingly
Frequent domestic and international travel and driving to site locations

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Exposure to passion, innovation, and scientific excellence
Full-time employment