Local Clinical Trial Manager – FSP

🔥 0 minutes ago

🌐 Belgium, Netherlands – Remote

🇧🇪 Belgium – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 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

• Achieve the final clinical deliverable within the customer contract timeframe • Lead local, within-country clinical operations teams and coordinate cross-functional experts, vendors, and clinical sites • Serve as the operational point of contact between central and in-country study teams • Support study feasibility, site selection, and local study performance • Deliver assigned studies within time, budget, quality, regulatory, and protocol expectations • Develop and maintain country study plans, timelines, budgets, resource estimates, milestones, and risk plans • Troubleshoot and resolve study-team issues and manage local supply inventory • Ensure accuracy of study systems, trial master files, databases, and monitoring-tracking tools • Identify and mitigate country/site-level risks and escalate issues affecting delivery • Review and approve monitoring visit reports and ensure monitoring activities are completed • Create and manage study budgets, site payments, contracts, and local vendor relationships • Develop study documents and manuals, including local informed consent forms and regulatory materials • Coordinate regulatory authority and ethics committee submissions and maintain required communications • Maintain knowledge of study compounds, protocols, disease areas, local treatment guidelines, and healthcare systems • Assist with audits and inspections and coordinate country responses and follow-up • Train in-country staff and investigator sites and coordinate local study meetings • Communicate with sites regarding protocol amendments and safety issues, including SAE reporting • Contribute to end-of-study learning debriefs and identify process improvements • Collaborate with medical, legal, finance, regulatory, and other functional teams

🎯 Requirements

• 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 quality requirements • Strong project management skills and ability to work and lead in a matrix team environment • Understanding of country local regulations, and basic understanding of other countries' regulations if required • Understanding of ICH-GCP guidelines and written standards • Good English written and verbal communication skills • Negotiation skills • Strong computer skills and willingness to learn new computer systems • Ability to understand and apply digital innovations to clinical trials • Conceptual, analytical, and strategic thinking, including data literacy • Problem-solving and conflict-resolution skills • Willingness and availability to travel as required

🏖️ Benefits

• Resources and support to achieve individual career goals • Training courses to improve personal/professional skills • Equal employment opportunity and affirmative action • Accessibility services and accommodations for job seekers with disabilities