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 10/31/2026full-timeRemote • MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

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 effective communication within multicultural teams.

Highest-signal resume keywords

Clinical Study ManagementICH GCP ComplianceClinical Monitoring PracticesLeadership and Team MotivationBudgeting and Financial Acumen

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial ManagementData Quality ManagementCRF Design and GuidelinesMonitoring Plan DevelopmentTrial Master File ManagementRegulatory SubmissionsClinical Metrics MonitoringQuery ResolutionEthics Committee CoordinationProject Deliverable Management

Soft Skills

Interpersonal SkillsProblem-Solving SkillsPlanning and Organizational SkillsEffective CommunicationJudgment and Decision-Making

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft Word

Industry Keywords

Clinical OperationsClinical TrialsMulticultural Matrix OrganizationStudy Start-Up ActivitiesAccompanied 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
Assume Clinical Study Manager responsibilities on small or less complex projects when required
Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans
Set up, organize, maintain, and archive Trial Master File sections and study materials
Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare and present at client, 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 teams on standardized clinical monitoring processes
Prepare and monitor clinical timelines and metrics; provide status updates and implement recovery actions
Review monitoring visit reports and manage CRF collection and query resolution
Monitor or co-monitor clinical trials and conduct Accompanied Field Visits when required
Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues
Coordinate study start-up activities and ethics committee and regulatory submissions
Review ethics committee questions and ensure essential document quality
Provide input to clinical activity forecasts and manage clinical resources, responsibilities, and additional resource needs
Ensure final clinical deliverables meet contractual time, quality, and cost expectations while maintaining profitability

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of comparable experience
Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
Leadership, mentoring, training, and team motivation skills
Planning and organizational skills
Interpersonal and problem-solving skills in a multicultural matrix organization
Ability to work effectively in changing environments with complex or 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
Frequent domestic and international travel

Benefits

Comp & perks

Fully remote work mode
Global team environment
Collaboration and development opportunities
Scientific excellence-focused work environment