Local Clinical Trial Manager – FSP

🔥 26 minutes ago

🇵🇱 Poland – 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

• Lead the within-country clinical operations study team and provide matrix leadership and project management • Act as the operational point of contact between central and country study teams • Collaborate with medical, regulatory, supply, finance, legal, vendor, and site staff • Conduct study feasibility and site selection; lead site selection and ensure local study performance • Deliver assigned studies on time, within budget, and to quality expectations under applicable regulations and guidelines • Develop and maintain country study plans, budgets, timelines, milestones, quality plans, and risk plans • Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection readiness • Troubleshoot and resolve country-level study issues and ensure site supplies and inventory • Maintain accurate study systems and the trial master file; review study databases for accuracy • Develop country/site risk assessments, mitigation plans, and issue escalations • Review and approve monitoring visit reports and ensure monitoring activities are completed • Manage study budgets, site payments, contracts, negotiations, and local vendors • Develop local study documents, plans, manuals, informed consent forms, and translations • Coordinate regulatory authority and ethics committee submissions, approvals, and communications • Maintain knowledge of the study compound, protocol, disease area, local guidelines, and healthcare systems • Assist with audits and inspections and support regulatory/compliance responses • Train in-country staff and investigator sites; coordinate investigator, monitor, and local training meetings • Manage safety issues and safety report handling, including SAE reporting • Communicate with sites regarding protocol amendments and collaborate with country and cross-functional staff • Coordinate end-of-study/program debriefs and identify process improvements • Travel as needed for the role

🎯 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 • Respiratory experience advantageous • Equivalent combination of education, training, and/or directly related experience may be considered • Strong understanding of clinical studies, drug development, sample management, and quality requirements • Strong project management and matrix-team leadership experience • Knowledge of local regulations, ICH-GCP guidelines, and written standards • Excellent English written and verbal communication skills • Proven negotiation skills • Strong computer skills and willingness to learn evolving systems • Ability to work effectively in a remote environment • Flexibility, resilience, learning agility, problem-solving, conflict-resolution, analytical, strategic, and data-literacy skills • Available and willing to travel for project-related activities • Ability to communicate effectively with diverse groups and work under pressure while managing multiple projects • Ability to use and learn standard office equipment and technology

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Training courses to improve personal/professional skills • Opportunities to gain client-dedicated experience • Supportive, technologically empowered work environment • Health and wellbeing support • Healthy and balanced working environment • Diverse and inclusive workplace valuing varied experiences, backgrounds, and perspectives

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