Clinical Trial Manager I/II

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

📋 Description

• Develop, coordinate, and execute Phase 1 clinical research trials at organizational facilities.

• Collaborate with principal investigators and act as a liaison among research subjects, client teams, investigators, and clinic operations teams.

• Plan logistics and allocate resources effectively.

• Monitor study progress in relation to milestones, client deliverables, budgets, and relevant regulations.

• Provide site management oversight, clinical monitoring, and central monitoring deliverables aimed at ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manage site interactions from post-activation to site closure, including recruitment and investigator payments.

• Identify risks associated with clinical data and processes, and create strategies for risk mitigation.

• Review the study scope, budget, protocol content, contractual obligations, and project parameters.

• Escalate risks impacting timelines, quality, budget, or contracted scope to the project manager.

• Participate in and present at key meetings, including Kick Off Meetings.

• Act as an escalation point for communications with investigator sites and accompany CRA team members to sites when necessary.

• Coordinate delivery transitions with Study Start Up, Patient Recruitment, Data Management, and other functional leaders.

• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensure CTMS, dashboards, and other systems are configured and accessible, including UAT and access/audit trail reviews.

• Coordinate both initial and ongoing training for the study team.

• Oversee CRA and Central Monitor resource allocation, site assignments, conduct, compliance, and delivery risks.

• Review oversight dashboards and clinical trial systems, including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards.

• Review documentation for site and central monitoring, ensuring revisions, approvals, specifications, and deadlines are adhered to.

• Provide updates on clinical deliverables and risk status to clients, project management, and leadership.

• Support readiness for inspections, corrective action plans, data cuts, and database lock deadlines.

• Supervise assigned CRAs and Central Monitors, providing performance feedback to line managers.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams in achieving project milestones.

• Demonstrated experience working in an international environment.

• Established expertise in site management and monitoring (clinical or central).

• Preferably experienced in risk-based monitoring.

• Understanding of financial principles related to clinical trial management and budget oversight.

• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.

• Proficient in computer skills.

• Strong communication, presentation, and interpersonal skills with project teams and sites.

• Excellent conflict resolution abilities.

• Capacity to apply problem-solving techniques to address complex issues and utilize a risk management approach to pinpoint and mitigate potential threats.

• Critical thinking skills to identify causes and suitable solutions when issues arise.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive company culture.

• Reasonable accommodations for applicants and employees with disabilities, when appropriate.