Senior Director, Regional Clinical Study Management

📋 Description

• • Provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers across the regional portfolio, including direct supervision of regional clinical study managers (rCSMs).
• • Accountable for the end-to-end delivery of regional clinical studies from feasibility through closeout, ensuring alignment with global timelines, budget, and quality standards.
• • Acts as regional lead for one or multiple clinical studies across a therapeutic area or program, serving as the primary point of escalation for operational issues within the region.
• • Leads and coordinates regional clinical operations teams, including external partners and FSP vendors, to ensure seamless execution of trial activities.
• • Drives regional strategy by shaping trial feasibility, country allocation, and site selection processes in collaboration with feasibility managers, country heads, and medical affairs.
• • Ensures inspection readiness for all regional studies throughout the study lifecycle by enforcing compliance with ICH/GCP, SOPs, and regulatory requirements.
• • Develops, reviews, and optimizes regional work instructions and SOPs to improve operational efficiency and standardization.
• • Monitors and improves key performance metrics including data entry accuracy, query resolution timelines, and site recruitment rates across the region.
• • Provides regional input into global study plans, including protocol design, drug labeling, comparator drug reimbursement status, and clinical supplies inventory management.
• • Collaborates with Clinical Business Operations to optimize investigator fees, site payment processes, and patient travel reimbursement workflows.
• • Strategically forecasts regional resource needs, establishes contingency plans for key personnel, and optimizes resource utilization across the study lifecycle.
• • Conducts performance evaluations, provides coaching and mentoring to direct reports, and supports individual professional development plans for clinical study managers and CRAs.
• • Participates in annual operating plan development, headcount planning, and budget allocation for the regional clinical operations team.
• • Champions cross-functional collaboration across departments to integrate diverse perspectives and best practices into regional trial execution.
• • Demonstrates deep therapeutic area expertise and encourages team members to develop similar expertise in assigned portfolio areas.
• • Promotes a culture of continuous learning, accountability, and innovation by fostering honest feedback, self-awareness, and results-oriented behaviors aligned with company global competencies.
• • Utilizes MS Office and project planning applications to manage regional study timelines, resources, and deliverables.
• • May require travel as dictated by business needs to support regional operations, site visits, or stakeholder meetings.