Global Clinical Trial Manager II

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, with an emphasis on patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manage site interactions from activation to closeout, including recruitment efforts and investigator payments.

• Identify essential data, process, and protocol execution risks, and formulate mitigation strategies.

• Review the study scope, budget, and protocol details; ensure the clinical project team comprehends contractual obligations.

• Recognize and escalate risks related to timelines, quality, budget, and contracted scope.

• Participate in and present during key meetings, such as Kick Off Meetings.

• Act as an escalation point for communications with investigator sites and provide support for site visits as necessary.

• Coordinate transitions with Study Start Up, Patient Recruitment, and Data Management to achieve study milestones.

• Develop and sustain clinical study tools and templates, including Clinical Monitoring Plans.

• Ensure CTMS, dashboards, and related systems are properly configured, tested, and maintained.

• Organize study-team training on protocols, CRFs, dashboards, SOPs, plans, and timelines.

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

• Guarantee the quality and visibility of deliverables in clinical monitoring, central monitoring, and site management.

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

• Ensure team adherence to monitoring strategies, CMP/SMP, and risk plans.

• Review site and central monitoring documentation, ensuring timely revisions, approvals, and delivery.

• Provide updates on client, project management, and leadership status, including risks and proposed solutions.

• Support compliance with protocol, SOPs, ICH GCP, and country regulations, ensuring readiness for inspections.

• Oversee CRAs and Central Monitors, evaluating compliance and assisting with corrective action plans.

• Aid in activities to meet data cut and database lock deadlines.

• Offer performance feedback regarding staff to line managers.

• May be assigned to larger, more complex trials.

⛳️ Requirements

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

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

• Demonstrated experience working in an international environment.

• Established expertise in site management and monitoring, whether clinical or central.

• Preferred experience with risk-based monitoring.

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

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

• Proficient computer skills.

• Strong communication, presentation, and interpersonal skills.

• Excellent conflict resolution abilities.

• Capability to apply problem-solving techniques for complex issues and employ a risk management approach.

• Critical thinking skills to identify causes and appropriate solutions.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations made when appropriate.