Clinical Trial Manager

Thermo Fisher Scientific

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

Posted 9/25/2026full-timeSan Isidro • MexicoSeniorLeadWebsite

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 clinical monitoring practices, project management, and financial acumen, with strong leadership and communication skills.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceFinancial AcumenProject CoordinationClinical Monitoring Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData Quality PlansTrial Master File ManagementCRF DesignRegulatory SubmissionsBudgetingForecastingProcess ImprovementProgram ManagementChange Management

Soft Skills

LeadershipMentoringProblem-SolvingCommunicationAttention to Detail

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical TrialsRegulatory ComplianceEthics CommitteeMulticultural Matrix OrganizationAccompanied Field Visits

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
Assume Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned
Develop clinical tools, monitoring plans, monitoring guidelines, data quality plans, and 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 and clinical teams on client meetings, bid defenses, hand-offs, timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Monitor clinical activity timelines and metrics, provide project status updates, review tracking tools and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution
Monitor trial performance and contractual obligations; conduct Accompanied Field Visits and manage project financials as needed
Communicate with study sites about protocols, patient participation, case report forms, and study-related issues
Coordinate study start-up activities, regulatory submissions, ethics committee questions, and regulatory compliance documentation as needed
Provide input into clinical activity forecasts
Manage clinical resources, delegate responsibilities, and identify additional resource requirements
May have limited line management responsibilities on assigned North American GPHS projects

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ years of previous experience providing relevant knowledge, skills, and abilities
An equivalency of appropriate education, training and/or directly related experience may be considered
Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, financial, and attention-to-detail skills
Effective oral and written communication skills, including English language proficiency
Comprehensive understanding of clinical monitoring practices, processes, and requirements
Strong understanding of change management principles
Strong 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, including Outlook, Excel, Word, and computerized applications
Ability to independently manage clinical-only studies
Ability to work in a multicultural matrix organization
Willingness and ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

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