Local Clinical Trial Manager - FSP

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Deliver clinical studies within time, budget, quality, protocol, contract, and regulatory expectations • Lead local in-country study teams and provide matrix leadership and project management • Act as operational point of contact between central and country study teams • Support study feasibility, site selection, and local study performance • Develop and maintain country study plans, budgets, forecasts, milestones, timelines, quality, and risk plans • Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection readiness • Provide troubleshooting and problem-resolution support • Ensure site supplies and local inventory are managed • Maintain accurate study systems and complete trial master files • Report study progress and monitor key risk and performance indicators • Develop country/site risk assessments and mitigation plans • Review and approve monitoring visit reports • Manage study budgets, site payments, vendors, contracts, and local resourcing • Develop study documents, plans, manuals, informed consent forms, and local regulatory materials • Coordinate regulatory authority and ethics committee submissions and approvals • Maintain communication with regulatory authorities and ethics committees • Maintain knowledge of the study compound, protocol, disease area, local treatment guidelines, and healthcare system • Support audits and inspections and provide country responses and follow-up • Train in-country staff and investigator sites and coordinate local study meetings • Ensure communication and engagement with clinical sites • Manage study-specific 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 stakeholders

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous CTM experience comparable to 1+ years experience in a CTM role • Previous experience in Respiratory would be advantageous • Experience in site monitoring • Knowledge of clinical study, drug development, sample management, and associated processes and quality requirements • Strong project management approach and ability to work and lead in a matrix team environment • Understanding of country local regulations, ICH-GCP guidelines, and written standards • Available and willing to travel for project-related activities as required • Good English language written and verbal communication skills • Proven negotiation skills • Strong computer skills and willingness to learn new or evolving computer systems • Ability to work effectively in a remote environment • Ability to understand and apply digital innovations to clinical trials • Conceptual, analytical, and strategic thinking including data literacy • Problem-solving and conflict resolution skills • Flexibility and learning agility

🏖️ Benefits

• Health and wellbeing support • Healthy and balanced working environment • Training courses to improve personal/professional skills • Relevant study and protocol training • Professional development opportunities • Remote work environment • Travel for project-related activities as required