Associate Director, Regional Clinical Study Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regional Clinical Study Management based in the United States. This is a strategic clinical operations leadership role overseeing regional delivery of clinical studies and portfolios across the full study lifecycle. You will lead regional clinical operations teams and external partners while serving as a key escalation point for complex operational issues. The role combines strategic planning, study execution, quality oversight, resource management, and cross-functional leadership. You will help shape feasibility, country and site selection, recruitment, regulatory submissions, data collection, and study closeout activities. A strong focus on inspection readiness, ICH/GCP compliance, operational excellence, and risk management will be central to your impact. You will collaborate closely with global study teams, country leadership, vendors, medical affairs, regulatory teams, and senior management. This remote U. S. -based opportunity is suited to an experienced clinical operations leader who thrives in a fast-paced, international, and highly collaborative environment. Accountabilities - Lead regional clinical operations for assigned studies or portfolios, establishing clear goals, driving effective decision-making, and resolving escalated issues. - Oversee regional study delivery from feasibility and startup through recruitment, execution, data collection, and closeout, ensuring alignment with global timelines and priorities. - Drive regional feasibility, country allocation, site selection, startup planning, recruitment timelines, regulatory submissions, and local adaptation of study documentation.

- Coordinate internal clinical teams, cross-functional stakeholders, and external vendors, providing regular study updates and escalating risks appropriately to global leadership. - Monitor regional study performance and ensure compliance with protocols, SOPs, ICH/GCP requirements, applicable regulations, and inspection-readiness standards. - Identify operational risks and quality concerns, implement corrective solutions, and prepare sites and teams for audits and regulatory inspections. - Guide CRA coaching and mentoring, support monitoring quality, and ensure appropriate creation, maintenance, and quality control of Trial Master File documentation. - Support clinical data collection, data entry, query resolution, clinical supplies planning, comparator drug considerations, and Clinical Study Report activities as required. - Select and manage regional vendors, negotiate and monitor regional study budgets, oversee resource utilization, and coordinate investigator fees, site payments, and patient reimbursement activities. - Develop and improve regional processes, tools, work instructions, and SOPs while promoting best practices, operational efficiency, and cross-functional knowledge sharing. - Mentor junior team members, delegate responsibilities effectively, support development plans, and build a high-performing clinical operations culture. - Travel as needed to support business and study requirements. Requirements - Bachelor’s degree in a scientific or healthcare discipline with 8+ years of progressive clinical operations experience in the biotechnology, pharmaceutical, or CRO industry; alternatively, a preferred master’s degree with 6+ years of relevant experience . - Proven leadership and management experience as a direct people manager or cross-functional clinical study leader. - Strong experience managing regional clinical studies or portfolios across planning, startup, recruitment, execution, quality, and closeout. - Demonstrated knowledge of clinical research operations, ICH/GCP, regulatory requirements, inspection readiness, study quality, and risk management.