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

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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 within multicultural teams.

Highest-signal resume keywords

Clinical Study ManagementICH GCP ComplianceClinical Monitoring PracticesProject Budget ManagementLeadership and Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringData Quality Plan DevelopmentCRF DesignRegulatory SubmissionsDocument ArchivingMonitoring Plan DevelopmentTrial Master File ManagementBudgeting and ForecastingQuality AssuranceResource Management

Soft Skills

Interpersonal SkillsProblem-Solving SkillsPlanning and Organizational SkillsJudgment and Decision-MakingEffective Communication

Tools & Technologies

Microsoft OutlookMicrosoft ExcelMicrosoft Word

Industry Keywords

Clinical OperationsRegulatory ComplianceEthics Committee ReviewMulticultural 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 such as 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 designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents
Collaborate with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborate with clinical teams and other departments to meet project deliverables
Lead team meetings and communicate regularly to maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Ensure timely archiving of documents and study materials
Achieve final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, reviewing monitoring visit reports, and managing 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 ensure timely ethics committee and regulatory submissions
Ensure essential document quality meets Regulatory Compliance Review expectations
Review and follow up on ethics committee questions
Provide input to 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 comparable experience providing relevant knowledge, skills, and abilities
Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
Leadership, mentoring, and training skills
Planning and organizational skills
Interpersonal and problem-solving skills in a multicultural matrix organization
Ability to work effectively in changing environments 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
Willingness/ability to frequently drive to site locations and travel domestically and internationally

Benefits

Comp & perks

Fully remote work arrangement
Global team environment
Collaboration and development opportunities
Passion, innovation, and scientific excellence-focused workplace