Local Clinical Trial Manager – FSP

🔥 16 minutes ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Lead the within-country clinical operations study team and manage study activities in Denmark • Serve as the operational point of contact between central and country study teams • Support study feasibility and site selection; lead site selection and remain accountable for local study performance • Deliver assigned studies within time, budget, quality, protocol, regulatory, and ICH-GCP requirements • Develop and maintain country study plans, forecasts, budgets, milestones, timelines, quality plans, and risk plans • Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection quality • Provide troubleshooting and problem-resolution support and manage local site supply inventory • Ensure accuracy of study systems and completeness of the trial master file • Report study progress to study teams and stakeholders; monitor risk and performance indicators • Develop country/site risk assessments, mitigation plans, and escalation processes • Review and approve monitoring visit reports and ensure required site monitoring activities are completed • Manage study budgets, expenditures, site payments, local vendors, contracts, and negotiations • Develop key study documents, plans, manuals, local informed consent forms, and required licenses • Coordinate clinical study application submissions to regulatory authorities and ethics committees • Maintain communication with regulatory authorities and ethics committees throughout the study • Maintain knowledge of the study compound, protocol, disease area, competitive landscape, treatment guidelines, and healthcare system • Support audits and inspections and provide country responses and follow-up • Coordinate and deliver investigator meetings, monitor meetings, and local training • Ensure appropriate training of country staff and investigator sites • Manage protocol amendment communications, study-specific safety issues, and SAE reporting • Coordinate end-of-study learning debriefs and identify improvements • Collaborate with medical, legal, finance, regulatory, supply, vendor, and other functional teams • Travel as needed for the role

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 3+ years of comparable experience • Experience in site monitoring • Experience and knowledge sufficient to perform the role; equivalent combinations of education, training, and directly related experience may be considered • Strong understanding of clinical studies, drug development, sample management, and associated quality requirements • Strong project management skills and ability to work in a matrix team environment • Understanding of local country regulations, ICH-GCP guidelines, and written standards • Excellent English written and verbal communication skills • Negotiation skills • Strong computer skills and willingness to learn evolving computer systems • Ability to work effectively in a remote environment • Ability and willingness to travel for project-related activities as required • Ability to apply conceptual, analytical, and strategic thinking, including data literacy • Effective problem-solving and conflict-resolution skills • Ability to understand and apply digital innovations to clinical trials • Ability to perform under pressure while prioritizing and handling multiple projects • Ability to communicate and work with diverse groups, including physicians, scientists, ethics boards, pharmacies, vendors, and clinical site staff

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Career development and training opportunities • Participation in relevant training courses to improve personal/professional skills • Accessibility accommodations for job seekers with disabilities • Equal employment opportunity and affirmative action environment

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