Clinical Team Manager – FSP, Country Study Manager

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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