Clinical Team Manager – FSP, Country Study Manager

🕒 vor 4 Tagen

🇧🇪 Belgien – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

👻 Geisterscore 10%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Thermo Fisher Scientific

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10.000+ Mitarbeiter

Gegründet 1956

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🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Deliver clinical studies within country according to protocol, timelines, budget, quality requirements and applicable regulations • Lead country feasibility, study planning and operational delivery of Phase I-IV clinical studies • Serve as operational point of contact between the Central Study Team and in-country staff • Assess study suitability for the local environment and conduct country/site feasibility • Lead site selection and remain accountable for site performance • Develop and maintain country study plans, forecasts, budgets, resource estimates, milestones, timelines, quality plans and risk plans • Select and manage local vendors, including oversight, agreements, payments, communications and issue management • Create and manage study budgets and report accruals to finance • Manage key study documents, plans, manuals, local recruitment materials and site support materials • Develop country/site risk assessments, mitigation plans and communicate risks to local and global teams • Assist with ethics committee/IRB submissions and, where applicable, Regulatory Authority submissions and approvals • Arrange translations of study documentation into local languages • Support and negotiate Clinical Trial Agreements with investigational sites • Ensure site supplies and manage local supply inventory • Coordinate in-country operational activities, site progress, protocol deviations, metrics, communications, issue escalation and monitoring-plan compliance • Build relationships with local medical staff and key partners, including ethics boards, pharmacies and vendors • Coordinate and deliver investigator meetings, monitor meetings, local training and in-country staff training • Conduct business-management monitoring activities to ensure study quality and integrity • Support regulatory/compliance audits and coordinate country responses and follow-up • Review monitoring tools, risk and performance indicators, reports, study databases and Monitoring Visit Reports • Escalate resourcing issues and ensure appropriate in-country study resourcing • Manage study-specific safety issues and safety report handling, including SAE reporting • Maintain accurate Sponsor Study Records and ensure study conduct follows regulations, ICH/GCP and client standards • Coordinate end-of-study/program learning debriefs and identify improvements • Maintain therapeutic-area, product, protocol and study-related knowledge through ongoing training

🎯 Anforderungen

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of comparable previous experience • Combination of appropriate education, training and/or directly related experience may be considered as an equivalency • Excellent leadership, mentoring, training, motivation and team-integration skills • Strong planning, organizational, interpersonal, problem-solving, judgment and decision-making skills • Ability to work in a changing environment with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes and requirements • English language proficiency and effective oral and written communication skills • Ability to evaluate workload against project budget and adjust resources accordingly • Knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word and client systems/software • Understanding of clinical study, drug development, sample management and quality requirements • Understanding of country local regulations, ICH-GCP guidelines and client written standards • Ability and willingness to travel domestically and internationally • Ability to collaborate effectively in multicultural matrix teams and remote environments • Ability to communicate and work effectively with senior medical staff, physicians and scientists

🏖️ Vorteile

• Fully remote work arrangement • Standard Monday-Friday work schedule • Professional and personal development through relevant training courses • Participation in training sessions to improve skills • Collaboration and development within a global team • Travel for project-related activities, including investigator and monitor meetings • Opportunity to contribute to scientific excellence and global R&D projects

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