Clinical Team Manager – Country Study Manager

🕒 il y a 4 jours

🇧🇪 Belgique – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Thermo Fisher Scientific

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10 000+ employés

🧬 Biotechnologie

💊 Pharmaceutique

🏥 Santé

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific est le leader mondial au service de la science. Sa mission est de permettre à ses clients de rendre le monde plus sain, plus propre et plus sûr. L’entreprise propose un vaste portefeuille d’instruments de laboratoire, de technologies analytiques, de solutions de diagnostic, de consommables, de logiciels et de services destinés à la recherche en sciences de la vie, aux analyses, au diagnostic clinique ainsi qu’au développement et à la fabrication de thérapies. Ses activités et ses offres, telles qu’elles sont présentées sur son site et dans ses communications, comprennent notamment des solutions d’imagerie avancée et des microscopes électroniques, des systèmes de chromatographie et de spectrométrie de masse, des tests génétiques et cliniques, l’automatisation des laboratoires et des outils d’IA, ainsi que des services de bioproduction et de développement et fabrication sous contrat (CDMO). Parmi ses marques figurent Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon et PPD. Thermo Fisher annonce un chiffre d’affaires annuel supérieur à 45 milliards de dollars et met en avant sa responsabilité sociétale, ainsi que ses programmes environnementaux et en faveur des communautés, en complément de ses produits et services scientifiques.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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