Clinical Team Manager – 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

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🏥 Gesundheitswesen

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific ist weltweit führend im Bereich „Serving Science“ und verfolgt die Mission, seine Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen. Das Unternehmen bietet ein umfassendes Portfolio an Laborinstrumenten, analytischen Technologien, Diagnostiklösungen, Verbrauchsmaterialien, Software und Services für die Life-Sciences-Forschung, analytische Tests, die klinische Diagnostik sowie die Entwicklung und Herstellung von Therapien. Zu den auf der Website und in den Unternehmensnachrichten beschriebenen Geschäftsbereichen und Angeboten gehören moderne Imaging-Systeme und Elektronenmikroskope, Chromatografie- und Massenspektrometriesysteme, genetische und klinische Tests, Laborautomation und AI-Tools, Bioprocessing sowie Services für die Auftragsentwicklung und -herstellung. Zu den genannten Marken zählen Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon und PPD. Thermo Fisher weist einen Jahresumsatz von mehr als 45 Milliarden US-Dollar aus und engagiert sich neben seinen wissenschaftlichen Produkten und Services für Corporate Social Responsibility sowie Umwelt- und Community-Programme.

Beschreibung

• Lead and manage operational implementation of country feasibility, planning, and delivery of Phase I–IV clinical studies • Serve as the operational point of contact between the Central Study Team and in-country staff • Deliver studies within the country according to protocol, timelines, budget, quality, and risk requirements • Provide input into study concepts, protocols, logistics, and local expert coordination • Assess study appropriateness 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 • Manage study budgets, expenditures, site payments, and accrual reporting to Finance • Manage key study documents, plans, manuals, local recruitment materials, and site support materials • Develop country/site risk assessments, mitigation plans, and management communications • Assist with ethics committee/IRB submissions and, where applicable, Regulatory Authority submissions and approvals • Arrange translations of key study documents into the local language • 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, escalation, and monitoring-plan compliance • Build relationships with local medical staff and key partners • Coordinate and deliver investigator meetings, monitor meetings, and local training • Ensure study quality and integrity through appropriate business management monitoring activities • Support regulatory/compliance audits and follow up on assessment and audit reports • Review monitoring tracking tools, risk and performance indicators, reports, and study databases for accuracy • Escalate resourcing issues and ensure appropriate in-country staffing • Review and approve Monitoring Visit Reports within agreed timelines • Manage and report study-specific safety issues, including SAE reporting • Ensure studies comply with applicable regulations, ICH/GCP, and client standards • Maintain accurate Sponsor Study Records • Coordinate end-of-study/program learning debriefs and identify improvements • Maintain therapeutic-area, product, protocol, ICH-GCP, and client-standard knowledge through ongoing training • Collaborate with country study staff, medical staff, physicians, scientists, ethics boards, pharmacies, and vendors

🎯 Anforderungen

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Good leadership, mentoring, and team motivation skills • Good planning and organizational skills • Solid interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Good judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets and adjust resources accordingly • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word, and computerized applications • Ability to travel domestically and internationally and frequently drive to site locations • Knowledge of country local regulations, ICH-GCP guidelines, and client written standards

🏖️ Vorteile

• Fully remote work mode • Standard Monday–Friday work schedule • Training courses and opportunities to improve personal/professional skills • Global team collaboration and professional development • Travel opportunities for project-related activities, including domestic and international travel

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