Senior Clinical Trial Manager, FSP

Thermo Fisher Scientific

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

Posted 10/31/2026full-timeRemote • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical operations and quality for complex studies, with a strong focus on compliance with ICH GCP and FDA guidelines. Proficient in clinical monitoring practices, project coordination, and effective communication within multicultural teams.

Highest-signal resume keywords

Clinical Operations ManagementICH/GCP ComplianceProject CoordinationClinical Monitoring PracticesFinancial Acumen

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementMonitoring Plans DevelopmentTrial Master File ManagementCRF DesignRegulatory SubmissionsBudgetingForecastingData Quality PlanChange Management PrinciplesRisk Management

Soft Skills

LeadershipMentoringProblem-SolvingInterpersonal SkillsAttention to Detail

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft Word

Industry Keywords

Clinical TrialsModerate- to High-Complexity StudiesEthics CommitteeMulticultural Matrix OrganizationAccompanied Field Visits

About the role

Key responsibilities & impact

Manage all clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP
Assume regional Lead CTM, Clinical Study Manager, process improvement, complex program management or project coordination responsibilities as required
Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan
Contribute to the Master Action Plan and ensure timely setup, organization, content and quality of Trial Master File sections
Participate in designing CRFs, CRF guidelines, patient informed consent templates and other protocol-specific documents
Collaborate with the project manager to prepare, organize and present at client meetings, including bid defense and hand-off meetings
Lead clinical team meetings and maintain timelines, resources, interactions and quality
Implement and train standardized clinical monitoring processes
Monitor clinical activity timelines and metrics, provide status updates, review projects and implement recovery actions
Review monitoring visit reports, manage CRF collection and query resolution, and monitor trial performance against contractual obligations
Conduct Accompanied Field Visits and manage project financials as required
Communicate with study sites about protocol, patient participation, case report forms and study-related issues
Coordinate study start-up activities and ensure essential document quality and timely regulatory submissions
Review and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, delegate responsibilities and identify additional resource requirements
Potentially perform limited line management responsibilities on assigned GPHS projects in North America

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ 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
Strong leadership, mentoring, training, team motivation and integration skills
Strong planning, organizational, prioritization, interpersonal and problem-solving skills
Solid understanding of change management principles
Comprehensive understanding of clinical monitoring practices, processes and requirements
Strong judgment, decision-making, escalation and risk management skills
Effective oral and written communication skills, including English language proficiency
Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
Strong attention to detail
In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines
Strong computer skills, including Outlook, Excel and Word
Ability to independently manage clinical-only studies
Ability to work in a multicultural matrix organization
Ability to frequently travel domestically and internationally
Office environment exposure to electrical office equipment

Benefits

Comp & perks

Fully remote work mode
Collaboration and development opportunities
Global team environment
Frequent domestic and international travel