Senior Non-Interventional Studies Clinical Team Manager

Thermo Fisher Scientific

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

Posted 9/22/2026full-timeRemote • BrazilSeniorWebsite

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 financial oversight, with strong leadership and communication skills.

Highest-signal resume keywords

Clinical Study 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 PracticesData Quality PlansTrial Master File ManagementCRF DevelopmentRegulatory SubmissionsBudgeting and ForecastingChange Management PrinciplesProject Status MonitoringResource ManagementRisk Management

Soft Skills

LeadershipInterpersonal SkillsProblem-SolvingAttention to DetailDecision-Making

Tools & Technologies

OutlookExcelWordComputerized Applications

Industry Keywords

Clinical TrialsModerate- to High-Complexity StudiesEthics Committee Follow-UpMulticultural Matrix OrganizationClient Meetings

About the role

Key responsibilities & impact

Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
Assume Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned
Develop clinical tools, monitoring plans, guidelines, data quality plans, and master action plans
Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials
Participate in development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
Lead clinical team meetings and coordinate departments to maintain timelines, resources, interactions, and quality
Implement and train teams on standardized clinical monitoring processes
Monitor clinical activity timelines, metrics, project status, recovery actions, monitoring visit reports, CRF collection, query resolution, trial performance, and contractual obligations
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 into clinical activity forecasts
Manage clinical resources, delegation, assignment of responsibilities, and additional resource requirements
Conduct accompanied field visits and manage project financials when applicable
In assigned North American GPHS projects, undertake limited line management responsibilities when applicable

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ years of previous experience, or equivalent combination of education, training, and/or directly related experience
Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and attention-to-detail skills
Strong understanding of change management principles
Comprehensive understanding of clinical monitoring practices, processes, and requirements
Strong oral and written communication skills, including English language proficiency
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, including Outlook, Excel, Word, and computerized applications
Ability to independently manage clinical-only studies
Ability to work in a multicultural matrix organization
Ability to evaluate workload against project budgets and adjust resources accordingly

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Passion, innovation, and commitment to scientific excellence