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, monitoring plans, and maintaining Trial Master Files while effectively collaborating with cross-functional teams.

Highest-signal resume keywords

Clinical Monitoring PracticesICH/GCP ComplianceProject ManagementLeadership and Team IntegrationFinancial Acumen

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Quality PlansCRF DesignMonitoring Guidelines DevelopmentProject Status UpdatesBudgeting and ForecastingRegulatory SubmissionsDocument ArchivingMonitoring Visit Reports ReviewQuery Resolution

Soft Skills

Interpersonal SkillsProblem-Solving SkillsEffective CommunicationPlanning and Organizational SkillsJudgment and Decision-Making

Tools & Technologies

OutlookExcelWord

Industry Keywords

Clinical OperationsTrial Master FilesEthics CommitteeMulticultural Matrix OrganizationAccompanied Field Visits

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, monitoring plans, monitoring guidelines, data quality plans, and clinical-related documents
Contribute to Master Action Plans and maintain the quality and organization of Trial Master Files
Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents
Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Collaborate with clinical and cross-functional teams to meet project deliverables
Lead team meetings and maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Archive study documents and materials in a timely manner
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, and implement recovery actions
Review monitoring visit reports and manage 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 when required in smaller regions
Communicate with study sites about protocol, patient participation, case report forms, and related issues
Coordinate study start-up activities and ethics committee and regulatory submissions when appropriate
Ensure essential document quality and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, 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
Equivalent combination of appropriate education, training and/or directly related experience may be considered
Leadership, mentoring, training, motivation, and team integration skills
Planning and organizational skills
Interpersonal and problem-solving skills
Ability to work in a multicultural matrix organization and changing environment with complex/ambiguous situations
Familiarity with clinical monitoring practices, processes, and requirements
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
Financial acumen and knowledge of budgeting, forecasting, and fiscal management
Strong attention to detail
Understanding of relevant regulations, including ICH/GCP and FDA guidelines
Computer skills using Outlook, Excel, Word, and similar applications
Ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Frequent domestic and international travel as part of the role