Senior Clinical Trial Manager, FSP

Thermo Fisher Scientific

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

Posted 10/31/2026full-timeRemote • MexicoSeniorWebsite

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 effective communication with stakeholders.

Highest-signal resume keywords

Clinical Trial ManagementICH/GCP ComplianceProject CoordinationFinancial AcumenLeadership and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Monitoring PracticesBudgetingForecastingRegulatory SubmissionsCRF DevelopmentData Quality Plan DevelopmentTrial Master File ManagementChange Management PrinciplesRisk ManagementStudy Start-Up Activities

Soft Skills

LeadershipInterpersonal SkillsProblem-SolvingDecision-MakingOrganizational Skills

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical StudiesModerate- to High-Complexity StudiesGovernment & Public Health StudiesEthics CommitteeClinical Resources Management

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
Assume regional Lead Clinical Trial Manager, Clinical Study Manager, process improvement, program management, or project coordination responsibilities as assigned
Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan
Contribute to the Master Action Plan and ensure timely organization, content, and quality of Trial Master File sections
Participate in the design and development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings
Lead clinical team meetings and coordinate timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Ensure timely archiving of study documents and materials
Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, 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 regarding protocols, patient participation, case report forms, and study-related issues
Coordinate study start-up activities and regulatory submissions when appropriate
Review and follow up on ethics committee questions
Prepare forecast estimates for clinical activities
Manage clinical resources, delegate responsibilities, and identify additional resource requirements
Provide limited line management for assigned Government & Public Health Studies 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 relevant knowledge, skills, and abilities
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, and risk-management skills
Strong understanding of change management principles
Comprehensive understanding of clinical monitoring practices, processes, and requirements
Effective oral and written communication skills, including English language proficiency
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 and proficiency with Outlook, Excel, Word, and computerized applications
Ability to independently manage clinical-only studies
Frequent travel to domestic and international site locations

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday-Friday work schedule
Collaboration and professional development opportunities
Mentoring and training opportunities
Global team environment
Domestic and international travel opportunities