Associate Director, Global Study Management Associate Lead

General Description

Provides management to Global Study Management Associates (gSMAs) at various levels in one or multiple regions, including line management, mentorship, coaching, and personal/career development. Responsible for assignment of qualified gSMA resources to studies that are aligned to deliverables and overall portfolio goals. Oversees training compliance for the gSMA team. Reviews data metrics, CTMS, eTMF, and other reports to identify risks and opportunities for improvement of gSMA key tasks.

Ensures that gSMAs’ supporting task delivery meets appropriate inspection readiness quality, timelines, and standards. Acts as a point of escalation for resolving issues for the gSMAs’ assigned studies. Actively drives best practices and process improvement to effectively support studies and teams. Accountable for leading PSM team process optimization initiatives, driving end to end process improvements in partnership with cross functional stakeholders to enhance efficiency, quality, and scalability across the organization.

Collaborates effectively with internal and external stakeholders at the regional and global levels to ensure that business needs are met. Supports/leads team to solve complex problems. Participates/leads in shaping gSMA team development strategy, applies strategic thinking in study management with significant influence within PSM and with cross function key stakeholders. Ensures optimal resourcing across studies to maximize effective utilization of gSMA capacity, including demand forecasting, workload balancing, and alignment with portfolio priorities.

Leads the interview, selection, and hiring of qualified gSMA staff as required to meet current and future business needs.

Driving Execution – change, communication, excellence, leadership

• Facilitates team onboarding and study handover to ensure business continuity
• Ensures timely assignment of qualified resources to each study to secure study delivery
• Ensures team has timely and adequate planning to deliver global clinical studies with high quality
• Ensures there are clear priorities and structures to deliver on key study objectives; manages overlapping priorities
• Drives team to improve efficiency and effectiveness by prioritizing tasks and improving performance
• Decisions and problem-solving are guided by policies, procedures, and department plans with guidance from the manager
• Embraces change and helps others understand the reason for the change; implements the change management framework
• Ensures operational processes, systems, and standards are adopted and implemented consistently across studies
• Maintains a working knowledge of and monitors the team’s compliance with applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and BeOne’s SOPs and WIs
• Displays high professional standards and exemplifies compliance with high-quality and ethical standards
• Proactively identifies gaps in current practice and initiates/leads the team to close the gaps
• Actively oversees the knowledge management process by ensuring that lessons learned are captured, retained, and leveraged for future work

Contributes to and is accountable for the team’s performance against key metrics; builds high-performing teams through judicious recruitment, career development, and promotion. Maintains and demonstrates a positive and results-oriented work environment and holds self and team accountable for conveying messages with empathy. Mentors and coaches team to realize their true potential and secure strong engagement and connection to BeOne’s mission, vision, and core values.

Understands what drives team members and how to get the best results from individual team members. Fosters a healthy feedback-oriented culture that rewards and encourages regular constructive feedback for individual and team growth. Champions a global mindset and approach to foster increased collaborative spirit and consistency across BeOne. Presents and explains information and communicates with stakeholders in a professional and confident manner with positive influence to broader team.

Escalates issues to the BeOne…