Local Clinical Trial Manager - FSP

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

📋 Description

• Execute clinical studies adhering to timelines, budgets, quality standards, protocols, contracts, and regulatory requirements.

• Lead local in-country study teams while providing matrix leadership and project management.

• Serve as the operational liaison between central and country study teams.

• Assist in study feasibility assessments, site selection, and local study performance optimization.

• Create and uphold country-specific study plans, budgets, forecasts, milestones, timelines, quality metrics, and risk management strategies.

• Track recruitment targets, patient recruitment timelines, data quality, and readiness for audits/inspections.

• Offer troubleshooting assistance and problem resolution support.

• Ensure proper management of site supplies and local inventory.

• Keep study systems accurate and maintain complete trial master files.

• Report on study progress and track key risk and performance metrics.

• Develop country/site risk assessments and mitigation strategies.

• Review and authorize monitoring visit reports.

• Oversee study budgets, site payments, vendor relationships, contracts, and local resource allocation.

• Generate study documents, plans, manuals, informed consent forms, and local regulatory materials.

• Coordinate submissions and approvals from regulatory authorities and ethics committees.

• Maintain communication with regulatory bodies and ethics committees.

• Stay informed about the study compound, protocol, disease area, local treatment guidelines, and healthcare systems.

• Support audits and inspections, providing country-specific responses and follow-ups.

• Train in-country personnel and investigator sites while organizing local study meetings.

• Ensure effective communication and engagement with clinical sites.

• Manage study-specific safety concerns and the handling of safety reports, including SAE reporting.

• Organize end-of-study learning debriefs and identify opportunities for improvement.

• Collaborate with stakeholders from medical, legal, finance, regulatory, vendor, pharmacy, and ethics sectors.

⛳️ Requirements

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

• Previous experience as a Clinical Trial Manager (CTM) with at least 1 year in a comparable role.

• Experience in the Respiratory field would be a plus.

• Background in site monitoring.

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

• Strong project management skills and the ability to lead within a matrix team environment.

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

• Willingness to travel for project-related tasks as necessary.

• Proficient in written and verbal English communication.

• Demonstrated negotiation abilities.

• Strong computer skills and eagerness to learn new or evolving systems.

• Capability to work effectively in a remote setting.

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

• Proficient in conceptual, analytical, and strategic thinking, including data literacy.

• Strong problem-solving and conflict resolution skills.

• Flexibility and a willingness to learn.

🏝️ Benefits

• Health and wellbeing support.

• A healthy and balanced working environment.

• Training opportunities to enhance personal and professional skills.

• Relevant study and protocol training.

• Opportunities for professional development.

• Flexible remote work environment.

• Travel for project-related activities when necessary.