Global Clinical Operations Leader – Clinical Trial Manager

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

📋 Description

• Lead the strategy and execution of global clinical operations for designated clinical trials.

• Drive the initiation of studies, including site selection, monitoring strategies, and operational planning.

• Coordinate cross-functional teams across various regions to ensure alignment on timelines, quality, and deliverables.

• Monitor the progress of studies, including recruitment, retention, data quality, and timelines, taking corrective actions as necessary.

• Identify potential risks early and implement mitigation and contingency strategies.

• Provide leadership guidance and performance feedback to project team members.

• Serve as the primary contact for sponsors regarding clinical operations matters.

• Ensure adherence to ICH GCP regulatory standards and internal procedures.

• Oversee the maintenance and quality of study documentation and central files.

• Support audits, inspections, and study closure activities, including database locking and archiving.

• Provide strategic oversight of the integrated data delivery (IDD) framework and promote a proactive data-quality culture.

⛳️ Requirements

• A degree in life sciences, nursing, or equivalent experience in clinical research.

• A minimum of 5 years of experience in leading clinical operations within a CRO setting.

• Demonstrated experience in roles such as Clinical Trial Manager, Clinical Project Manager, or Clinical Operations Leader.

• Strong understanding of ICH GCP regulatory requirements and clinical trial processes.

• Experience in coordinating cross-functional teams and managing study timelines, budgets, and quality.

• Proficient with clinical systems and standard tools like CTMS, EDC, and eTMF.

🏝️ Benefits

• Competitive salary

• Health insurance

• Retirement plans

• Professional development

• Remote work options