Senior Clinical Trial Manager, FSP

Thermo Fisher Scientific

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

Posted 10/30/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical operational and quality aspects of complex studies, with a strong focus on compliance with ICH GCP and FDA guidelines. Proficient in clinical monitoring practices, project management, and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceProject CoordinationLeadership and MentoringBudgeting and Fiscal Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Monitoring PracticesData Quality ManagementTrial Master File ManagementCRF DevelopmentRegulatory SubmissionsMonitoring Plan DevelopmentProject Financial ManagementChange Management PrinciplesResource ManagementRisk Management

Soft Skills

LeadershipInterpersonal SkillsProblem-SolvingAttention to DetailDecision-Making

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft WordComputerized Applications

Industry Keywords

Clinical TrialsModerate- to High-Complexity StudiesInformed Consent TemplatesClient MeetingsStudy Start-Up ActivitiesEthics Committee Follow-UpClinical Activity Forecasts

About the role

Key responsibilities & impact

Manage 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, program management, or project coordination responsibilities as assigned
Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans
Set up, organize, maintain, and archive relevant Trial Master File documents and study materials
Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborate with clinical teams and other departments, lead team meetings, and maintain timelines, resources, interactions, and quality
Implement and train standardized clinical monitoring processes
Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable
Provide input to clinical activity forecasts
Manage clinical resources, delegate responsibilities, and identify additional resource requirements
Conduct accompanied field visits and manage project financials when required
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
An equivalency combining 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, financial, and attention-to-detail skills
Understanding of change management principles
Comprehensive understanding of clinical monitoring practices, processes, and requirements
Effective oral and written communication skills, including English language proficiency
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
Willingness and ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

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