Clinical Team Manager – Country Study Manager

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

📋 Description

• Oversee and direct the operational execution of country feasibility, planning, and the delivery of Phase I–IV clinical trials.

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

• Ensure studies are executed within the country in accordance with the protocol, timelines, budget, quality, and risk requirements.

• Contribute insights into study concepts, protocols, logistics, and coordination with local experts.

• Evaluate the suitability of studies for the local context and perform country/site feasibility assessments.

• Lead the site selection process and remain accountable for site performance.

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

• Choose and oversee local vendors, managing oversight, contracts, payments, communications, and issue resolutions.

• Administer study budgets, manage expenditures, site payments, and accrual reporting to the Finance department.

• Handle key study documentation, including plans, manuals, local recruitment materials, and site support documents.

• Develop risk assessments for the country/site, mitigation strategies, and management communication plans.

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

• Facilitate the translation of essential study documents into the local language.

• Support and negotiate Clinical Trial Agreements with investigational sites.

• Ensure availability of site supplies and manage local supply inventory.

• Coordinate in-country operational activities, site progress, protocol deviations, metrics, communications, escalation, and compliance with the monitoring plan.

• Cultivate relationships with local medical personnel and key stakeholders.

• Organize and conduct investigator meetings, monitor meetings, and local training sessions.

• Maintain study quality and integrity through diligent business management monitoring activities.

• Assist with regulatory and compliance audits and follow up on assessment and audit findings.

• Review monitoring tracking tools, risk and performance metrics, reports, and study databases for accuracy.

• Address resourcing challenges and ensure appropriate in-country staffing levels.

• Review and approve Monitoring Visit Reports within the established timelines.

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

• Ensure studies adhere to applicable regulations, ICH/GCP standards, and client requirements.

• Maintain precise Sponsor Study Records.

• Organize end-of-study/program debriefs to identify areas for improvement.

• Stay updated on therapeutic areas, products, protocols, ICH-GCP, and client standards through continuous training.

• Collaborate with country study staff, medical professionals, physicians, scientists, ethics boards, pharmacies, and vendors.

⛳️ Requirements

• Bachelor's degree or equivalent relevant academic/vocational qualification.

• Over 5 years of experience providing the necessary knowledge, skills, and abilities for the role.

• Consideration for equivalency through a combination of appropriate education, training, and/or relevant experience.

• Strong leadership, mentoring, and team motivation capabilities.

• Excellent planning and organizational skills.

• Effective interpersonal and problem-solving abilities in a multicultural matrix environment.

• Capacity to thrive in dynamic settings with complex or ambiguous situations.

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

• Sound judgment and decision-making abilities.

• Proficient oral and written communication skills, including fluency in English.

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

• Financial acumen and understanding of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

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

• Proficient computer skills, including Outlook, Excel, Word, and other computerized applications.

• Willingness to travel domestically and internationally, including frequent driving to site locations.

• Understanding of local country regulations, ICH-GCP guidelines, and client-written standards.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Access to training courses and opportunities for personal and professional development.

• Collaboration with a global team and opportunities for professional growth.

• Travel opportunities related to project activities, including both domestic and international travel.