Local Clinical Trial Manager – FSP

🔥 26 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟢 Junior

🧪 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

• Deliver clinical study results within contracted time, quality, and cost expectations • Lead in-country clinical operations teams, cross-functional experts, vendors, and clinical site staff • Act as operational point of contact between central and in-country study teams • Conduct or support study feasibility, site selection, and local study performance management • Develop and maintain country study plans, timelines, budgets, milestones, risks, and recruitment targets • Troubleshoot and resolve study delivery issues • Ensure supplies are available at sites and manage local supply inventory • Maintain accurate study systems and complete trial master files • Report study progress and monitor risk and performance indicators • Develop risk assessments and mitigation plans • Review and approve monitoring visit reports • Create and manage study budgets, site payments, contracts, and local vendors • Develop local study documents, plans, manuals, and informed consent forms • Coordinate regulatory authority and ethics committee submissions and communications • Maintain knowledge of the study compound, protocol, disease area, treatment guidelines, and healthcare system • Support audits and inspections • Train in-country staff and investigator sites and coordinate local study meetings • Manage safety issues and safety report handling, including SAE reporting • Coordinate end-of-study learning debriefs and identify improvements • Collaborate with medical, legal, finance, regulatory, vendor, pharmacy, and ethics-board stakeholders

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 1+ years of experience in a CTM role • Previous experience in site monitoring • Oncology experience advantageous • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Strong understanding of clinical study, drug development, sample management, and associated quality requirements • Strong project management skills and ability to lead in a matrix team environment • Understanding of country local regulations, ICH-GCP guidelines, and written standards • Excellent English written and verbal communication skills • Negotiation skills • Strong computer skills and ability to learn evolving computer systems • Ability to work effectively in a remote environment • Willingness and availability to travel as required • Ability to perform under pressure, prioritize, and handle multiple projects • Ability to use and learn standard office equipment and technology

🏖️ Benefits

• Remote work arrangement • Career development opportunities • Training courses to improve personal/professional skills • Accessibility accommodations during the application process

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