Clinical Trial Manager II

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, compliance with protocols/GCP/regulatory standards, and data integrity.

• Manage site interactions from activation to closeout, including the recruitment process and payments to investigators.

• Identify key risks related to data, processes, and protocol implementation, and create mitigation strategies.

• Review the study scope, budget, and protocol details; communicate contractual responsibilities to CRAs and Central Monitors.

• Recognize and escalate risks associated with timelines, quality, budget, and contracted scope.

• Actively participate in and present during essential meetings, including Kick-Off Meetings.

• Serve as a point of escalation for investigator site personnel and engage with principal investigators and site staff through phone or in-person interactions.

• Collaborate with Study Start-Up, Patient Recruitment, and Data Management teams to meet study milestones.

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

• Ensure that CTMS, dashboards, and other systems are properly configured, accessible, and subject to necessary User Acceptance Testing (UAT) and audit-trail reviews.

• Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, plans, and timelines.

• Oversee the allocation of CRAs and Central Monitors, site assignments, conduct, compliance, and delivery risks.

• Ensure the quality and transparency of clinical monitoring, central monitoring, and site management deliverables.

• Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards to supervise site and patient activities.

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

• Review documentation for site and central monitoring to ensure quality, compliance, patient safety, trial conduct, and data integrity.

• Engage with clients, project management, leadership, and functional departments to provide updates and solutions.

• Support readiness for inspections related to clinical trial management.

• Supervise CRAs and Central Monitors, evaluate compliance and emerging risks, and facilitate corrective action plans.

• Assist in achieving deadlines for data cuts and database locks.

• Offer performance feedback for staff to line managers.

• May be assigned to oversee larger and more complex trials.

⛳️ Requirements

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

• Proven ability to lead and align teams to achieve project milestones.

• Experience working in an international setting.

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

• Preferred experience in risk-based monitoring.

• Understanding of financial principles and budget management in clinical trial management.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

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

• Excellent conflict resolution abilities.

• Capability to apply problem-solving techniques to address complex issues and utilize a risk-management approach to identify and mitigate threats to successful clinical research projects.

• Critical thinking skills to determine root causes and devise appropriate solutions when issues arise.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Emphasis on a Total Self culture.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.