Senior Clinical Trial Manager, FSP

Thermo Fisher Scientific

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

Posted 10/30/2026full-timeRemote • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical operational and quality aspects of studies, with a strong focus on compliance with ICH GCP and FDA guidelines. Proficient in developing clinical tools, monitoring plans, and effectively communicating with study sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring PracticesICH/GCP ComplianceLeadership and Team IntegrationFinancial Acumen and BudgetingProject Coordination and Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementData Quality PlansTrial Master File DevelopmentCRF DevelopmentRegulatory SubmissionsMonitoring GuidelinesChange Management PrinciplesRisk ManagementForecastingQuery Resolution

Soft Skills

LeadershipMentoringProblem-SolvingDecision-MakingEffective Communication

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical TrialsModerate- to High-Complexity StudiesEthics Committee Follow-UpStudy Start-Up ActivitiesPatient Participation

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
Develop clinical tools, monitoring plans, monitoring guidelines, data quality plans, master action plans, and Trial Master File sections
Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Prepare and present client meetings, including bid defense and hand-off meetings
Collaborate with clinical teams and other departments; lead team meetings and implement standardized monitoring processes and training
Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
Communicate with study sites regarding protocols, patient participation, case report forms, and study-related issues
Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable
Provide input into clinical activity forecasts
Manage clinical resources, delegation of responsibilities, and additional resource requirements
May assume regional Lead CTM, Clinical Study Manager, process improvement, program management, project coordination, or limited line-management responsibilities

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ years of comparable experience
Equivalency may consist of appropriate education, training and/or directly related experience
Strong leadership, mentoring, training, motivation, and team integration skills
Strong planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk-management skills
Solid understanding of change-management principles
Comprehensive understanding of clinical monitoring practices, processes, and requirements
Effective oral and written communication skills, including English language proficiency
Financial acumen and knowledge of budgeting, forecasting, and fiscal management
In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines
Strong computer skills with Outlook, Excel, Word, and computerized applications
Ability to independently manage clinical-only studies
Willingness and ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Commitment to scientific excellence