Local Clinical Trial Manager – FSP

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Deliver the final clinical output within the timeframe specified in the customer contract.

• Lead local clinical operations teams within the country and coordinate with cross-functional experts, vendors, and clinical sites.

• Act as the operational liaison between central and in-country study teams.

• Aid in study feasibility, site selection, and monitoring local study performance.

• Complete assigned studies in accordance with timelines, budget constraints, quality standards, regulatory requirements, and protocol expectations.

• Create and manage country-specific study plans, timelines, budgets, resource forecasts, milestones, and risk management plans.

• Address and resolve issues within the study team and oversee local supply inventory.

• Ensure the integrity of study systems, trial master files, databases, and monitoring-tracking tools.

• Identify and mitigate risks at the country/site level and escalate issues that may impact delivery.

• Review and authorize monitoring visit reports, ensuring that monitoring activities are fulfilled.

• Develop and oversee study budgets, site payments, contracts, and relationships with local vendors.

• Create study documents and manuals, including local informed consent forms and regulatory documentation.

• Coordinate submissions to regulatory authorities and ethics committees, maintaining necessary communications.

• Stay informed about study compounds, protocols, disease areas, local treatment guidelines, and healthcare systems.

• Support audits and inspections, coordinating responses and follow-ups at the country level.

• Train in-country staff and investigator sites, as well as organize local study meetings.

• Communicate with sites regarding protocol amendments and safety concerns, including SAE reporting.

• Participate in end-of-study learning debriefs and identify opportunities for process improvements.

• Collaborate with teams in medical, legal, finance, regulatory, and other functional areas.

⛳️ Requirements

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

• Minimum of 3 years of relevant experience.

• Experience in site monitoring.

• Familiarity with clinical studies, drug development, sample management, and associated quality standards.

• Strong project management capabilities and the ability to lead in a matrix team environment.

• Knowledge of local country regulations and a basic understanding of regulations in other countries as necessary.

• Comprehension of ICH-GCP guidelines and written standards.

• Proficient English written and verbal communication abilities.

• Negotiation proficiency.

• Strong computer skills with a willingness to learn new systems.

• Ability to comprehend and implement digital innovations in clinical trials.

• Conceptual, analytical, and strategic thinking skills, including data literacy.

• Problem-solving and conflict resolution capabilities.

• Openness and availability to travel as needed.

🏝️ Benefits

• Resources and support to help achieve individual career objectives.

• Training programs aimed at enhancing personal and professional skills.

• Commitment to equal employment opportunities and affirmative action.

• Accessibility services and accommodations for job applicants with disabilities.