Clinical Trial Manager

Thermo Fisher Scientific

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

Posted 10/30/2026full-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, managing timelines, and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Clinical Monitoring PracticesICH/GCP ComplianceProject Financial ManagementEffective Communication SkillsLeadership and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Quality PlansTrial Master File ManagementCRF DesignBudgeting and ForecastingRegulatory SubmissionsMonitoring Visit ReportsQuery ResolutionDocument ArchivingClinical Resource Management

Soft Skills

LeadershipProblem-SolvingOrganizational SkillsInterpersonal SkillsDecision-Making

Tools & Technologies

OutlookExcelWordAutomated Systems

Industry Keywords

Clinical OperationsQuality AssuranceEthics CommitteeMulticultural Matrix OrganizationClinical Study Start-Up

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
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 on client meetings, bid defenses, and hand-off meetings
Collaborate with clinical teams and departments to maintain timelines, resources, interactions, and quality
Lead team meetings and implement and train standardized clinical monitoring processes
Archive documents and study 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/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
Ensure essential document quality and follow up on ethics committee questions
Provide input 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 previous experience providing the knowledge, skills, and abilities to perform the job
Equivalency may consist of a combination of appropriate education, training and/or directly related experience
Good leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills
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 accordingly
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 using Outlook, Excel, Word, and similar automated systems
Ability to work effectively in a changing environment with complex/ambiguous situations
Ability to work in a multicultural matrix organization

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Exposure to passion, innovation, and scientific excellence