Associate Director – Regional Clinical Study Management

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

📋 Description

• Oversee the Regional Clinical Study Management (rCSM) function throughout Southeast Asia, offering strategic guidance, operational management, and leadership for BeOne Regional Clinical Study Managers.

• Create and execute Regional Clinical Study Management strategies that align with Global Clinical Operations goals, corporate priorities, and the business objectives of Southeast Asia.

• Assemble, lead, and cultivate a high-performing team of BeOne Regional Clinical Study Managers (rCSMs) through effective workforce planning, recruitment, onboarding, coaching, performance evaluation, succession planning, and ongoing professional development.

• Provide functional leadership, onboarding assistance, and capability enhancement for Functional Service Provider (FSP) Regional Clinical Study Managers in collaboration with the vendor.

• Establish regional study governance to oversee portfolio performance, track key milestones, timelines, quality, budgets, resources, and operational metrics.

• Promote operational excellence by refining Regional Clinical Study Management processes, leveraging digital innovations, implementing standardized best practices, and fostering a culture of continuous improvement.

• Engage directly with key investigators, strategic sites, and underperforming sites to address operational challenges, enhance enrollment, and ensure successful study execution.

⛳️ Requirements

• Bachelor's degree or higher (preferably in life sciences, including medicine, nursing, biology, or laboratory technology).

• A minimum of 13 years of experience in clinical research, clinical development, or drug development within the biotechnology, pharmaceutical, CRO, or related healthcare sectors.

• At least 8 years of experience in clinical project management and/or Regional Clinical Study Management, demonstrating responsibility for leading regional or global clinical trials.

• A minimum of 3–5 years of experience in people management, including leading and developing high-performing teams.

• Comprehensive understanding of ICH-GCP, applicable regulatory requirements, and global clinical trial processes.

• Experience in managing multi-country clinical trials across Southeast Asia or other regions is preferred.

• Project Management Professional (PMP) certification or an equivalent project management credential is preferred.

• Proven experience in managing cross-functional teams and influencing stakeholders within a matrix organization.

🏝️ Benefits

• Competitive market compensation package, which includes a performance-based annual bonus scheme.

• Company shares with a generous welcome grant!

• Opportunities for in-house and external learning and development.

• Excellent benefits program with continuous improvements!