Local Clinical Trial Manager

Thermo Fisher Scientific

. Accountable for achieving final clinical deliverables within contracted timelines .

Posted 10/7/2026full-timeRemote • DenmarkMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study management, including site monitoring, project management, and regulatory compliance. Proficient in developing study plans, budgets, and maintaining communication with stakeholders while ensuring adherence to ICH-GCP guidelines.

Highest-signal resume keywords

Clinical Study ManagementProject ManagementSite MonitoringRegulatory ComplianceStrong English Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical StudyDrug DevelopmentSample ManagementProject ManagementRisk ManagementData LiteracyRegulatory SubmissionsMonitoring Visit ReportsSafety Report HandlingBudget Development

Soft Skills

Negotiation SkillsProblem-SolvingConflict ResolutionFlexibilityResilience

Tools & Technologies

Study SystemsTrial Master FilesComputer Systems

Industry Keywords

ICH-GCP GuidelinesLocal RegulationsClinical TrialsStakeholder CommunicationAudit Support

About the role

Key responsibilities & impact

Accountable for achieving final clinical deliverables within contracted timelines
Lead the local study team and manage study activities within Denmark and other assigned countries
Serve as the operational point of contact between central and in-country study teams
Conduct study feasibility, site selection, and oversee local study performance
Deliver studies on time, within budget, and to quality expectations under applicable regulations and guidelines
Develop and maintain country study plans, budgets, resource estimates, milestones, timelines, and risk plans
Troubleshoot and resolve study-team issues and ensure site supplies and inventory
Maintain accurate study systems and trial master files and report progress to stakeholders
Monitor risk and performance indicators and review study databases for accuracy
Review and approve monitoring visit reports and ensure monitoring activities are completed
Manage local vendors, contracts, payments, communications, and issue resolution
Develop study documents, plans, manuals, informed consent forms, and regulatory submissions
Maintain communication with regulatory authorities and ethics committees
Support audits, inspections, regulatory compliance, and corrective follow-up
Coordinate training, investigator meetings, monitor meetings, and local study meetings
Manage safety issues and safety report handling, including SAE reporting
Collaborate with medical, legal, finance, regulatory, vendor, site, and external investigator stakeholders
Participate in end-of-study learning debriefs and identify process improvements
Travel as needed for the role

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
3+ years of comparable experience
Experience in site monitoring
Knowledge of clinical study, drug development, sample management, and associated processes and quality requirements
Strong project management skills and ability to work and lead in a matrix team environment
Understanding of country local regulations and, if required, other countries' regulations, ICH-GCP guidelines, and written standards
Strong English written and verbal communication skills
Negotiation skills
Strong computer skills and ability to learn new or evolving computer systems
Ability to work effectively in a remote environment
Willingness and availability to travel for project-related activities
Ability to understand and apply digital innovations to clinical trials
Conceptual, analytical, strategic thinking, and data literacy
Problem-solving and conflict resolution skills
Flexibility, resilience, and high learning agility

Benefits

Comp & perks

Health and wellbeing support
Accessibility services and accommodations for job seekers with disabilities
Equal employment opportunity and affirmative action employer
Remote work arrangement