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 10/30/2026full-timeMexicoMid-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 study activities, and leading teams to achieve project deliverables within timelines and budgets.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceClinical Monitoring PracticesBudgeting And Fiscal ManagementEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementMonitoring Plans DevelopmentCRF Design And GuidelinesData Quality Plan ImplementationRegulatory SubmissionsDocument ArchivingProject Timeline ManagementMetrics MonitoringResource AllocationEthics Committee Review

Soft Skills

LeadershipMentoringProblem-SolvingPlanning And OrganizationInterpersonal Skills

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft WordComputerized Applications

Industry Keywords

Clinical OperationsTrial Master FilePatient Informed ConsentAccompanied Field VisitsStudy Start-Up Activities

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 and/or less complex projects when required
Develop clinical tools, including 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 and developing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents
Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborate with clinical teams and other departments to meet project deliverables
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train standardized clinical monitoring processes
Ensure timely archiving of documents and study materials
Achieve final clinical deliverables within contractual timelines by preparing and monitoring timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
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 ensure timely ethics committee and regulatory submissions when appropriate
Ensure essential document quality meets Regulatory Compliance Review expectations
Review and follow up on ethics committee questions
Provide input into clinical activity forecast estimates
Manage clinical resources, assign and delegate responsibilities, and identify 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
Good leadership, mentoring, training, motivation, and team integration skills
Good planning and organizational skills
Solid interpersonal and problem-solving skills
Ability to work effectively in a changing environment with complex/ambiguous situations
Familiarity with clinical monitoring practices, processes, and requirements
Good judgment and decision-making skills
Effective oral and written communication skills, including English language proficiency
Ability to evaluate workload against project budget and adjust resources accordingly
Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management
Strong attention to detail
Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines
Good computer skills, including Outlook, Excel, Word, and computerized applications
Ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

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