Clinical Team Manager – FSP, Country Study Manager

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Execute clinical studies domestically in accordance with protocols, timelines, budgets, quality standards, and relevant regulations.

• Oversee country feasibility, study planning, and the operational execution of Phase I-IV clinical studies.

• Act as the operational liaison between the Central Study Team and local staff.

• Evaluate study compatibility with the local context and perform country/site feasibility assessments.

• Direct site selection and maintain accountability for site performance outcomes.

• Formulate and uphold country-specific study plans, forecasts, budgets, resource estimates, milestones, timelines, quality plans, and risk management plans.

• Choose and oversee local vendors, including managing contracts, payments, communications, and issue resolution.

• Construct and oversee study budgets while reporting accruals to the finance department.

• Manage essential study documents, plans, manuals, local recruitment materials, and site support documents.

• Develop country/site risk assessments and mitigation strategies, communicating risks to both local and global teams.

• Assist with submissions to ethics committees/IRBs and, when necessary, Regulatory Authority submissions and approvals.

• Organize translations of study documentation into local languages.

• Facilitate and negotiate Clinical Trial Agreements with investigational sites.

• Ensure the provision of site supplies and manage local inventory levels.

• Coordinate operational activities within the country, including site progress, protocol deviations, metrics, communications, issue escalation, and compliance with monitoring plans.

• Build and maintain relationships with local medical personnel and key stakeholders, such as ethics boards, pharmacies, and vendors.

• Organize and conduct investigator meetings, monitoring meetings, local training, and training for in-country staff.

• Perform business-management monitoring activities to ensure the quality and integrity of studies.

• Assist with regulatory/compliance audits and coordinate responses and follow-ups at the country level.

• Review monitoring tools, risk and performance indicators, reports, study databases, and Monitoring Visit Reports.

• Address resourcing challenges and ensure appropriate study resourcing within the country.

• Manage study-specific safety concerns and handle safety report processes, including SAE reporting.

• Keep accurate Sponsor Study Records and ensure compliance with regulations, ICH/GCP, and client standards.

• Coordinate learning debriefs at the end of studies/programs and identify potential improvements.

• Maintain ongoing knowledge of therapeutic areas, products, protocols, and study-related information through continuous training.

⛳️ Requirements

• Bachelor’s degree or equivalent qualification, along with relevant formal academic or vocational training.

• A minimum of 5 years of relevant experience in a comparable role.

• A combination of suitable education, training, and/or directly related experience may be accepted as an equivalency.

• Exceptional leadership, mentoring, training, motivational, and team integration abilities.

• Strong skills in planning, organization, interpersonal communication, problem-solving, judgment, and decision-making.

• Capable of working in a dynamic environment with complex or ambiguous situations.

• Familiarity with clinical monitoring practices, processes, and requirements.

• Proficient in English, with effective oral and written communication skills.

• Ability to assess workload against project budgets and adjust resources as necessary.

• Knowledge of budgeting, forecasting, and financial management.

• High attention to detail.

• Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficient in computer skills, including Outlook, Excel, Word, and client systems/software.

• Understanding of clinical studies, drug development, sample management, and quality requirements.

• Familiarity with local regulations, ICH-GCP guidelines, and client-specific written standards.

• Willingness and ability to travel domestically and internationally.

• Ability to effectively collaborate in multicultural matrix teams and remote work settings.

• Capacity to communicate and work productively with senior medical staff, physicians, and scientists.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.

• Opportunities for professional and personal development through relevant training courses.

• Participation in training sessions to enhance skill sets.

• Engagement and development within a global team environment.

• Travel opportunities for project-related activities, including investigator and monitor meetings.

• Opportunity to contribute to scientific excellence and global R&D initiatives.