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-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, managing project timelines, and leading teams to achieve clinical deliverables within budget and quality expectations.

Highest-signal resume keywords

Clinical Study ManagementICH/GCP ComplianceClinical Monitoring PracticesFinancial AcumenEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementMonitoring Plans DevelopmentCRF DevelopmentRegulatory SubmissionsProject BudgetingData Quality PlanningTrial Master File ManagementMetrics MonitoringResource ManagementDocument Archiving

Soft Skills

Leadership SkillsInterpersonal SkillsProblem-Solving SkillsOrganizational SkillsTeam Motivation

Tools & Technologies

OutlookExcelWord

Industry Keywords

Clinical OperationsQuality AssuranceEthics 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
Assume Clinical Study Manager responsibilities on small or less complex projects when required
Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan
Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections
Participate in development of 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 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
Archive study documents and materials in a timely manner
Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, 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 in smaller regions when required
Communicate with study sites regarding protocols, patient participation, case report forms, and related issues
Coordinate study start-up activities and timely ethics committee and regulatory submissions
Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions
Provide input into clinical activity forecasts
Manage clinical resources, delegate clinical responsibilities, and identify additional resource requirements
Achieve final clinical deliverables within 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 previous experience providing the knowledge, skills, and abilities to perform the job
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Leadership, mentoring, training, and team motivation skills
Planning and organizational skills for workload prioritization
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 budgets 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 computerized applications
Frequent domestic and international travel and driving to site locations

Benefits

Comp & perks

Fully remote work mode
Standard Monday-Friday work schedule
Collaboration and development opportunities
Global team environment
Passion, innovation, and scientific excellence culture