Director, Program Lead, Clinical Data Management

Director, Program Lead, Clinical Data Management Leads program-level strategy and execution across multiple programs or therapeutic areas, serving as the Global Clinical Data Management subject matter expert for program decisions. Oversees cross-program consistency, quality, and resource allocation (in collaboration with the Clinical Data Manager Operations team) and ensures adherence to the team standards, data quality expectations, and regulatory requirements. Provides leadership and direction to program teams, identifies and mitigates operational risks, and partners with senior functional and TA stakeholders to drive delivery excellence and continuous improvement.

Own program- and portfolio-level data management strategy and plans across all data modalities (eCRF [electronic Case Report Form], labs, biomarkers, PRO [Patient Reported Outcome]/eCOA [electronic Clinical Outcome Assessment], imaging, etc.), aligned with development plans, trial protocols, regulatory deliverables, Global Data Management & Standards, and Book of Business–driven resourcing. Lead risk-based planning, timelines, and inter-study dependencies across larger and more complex portfolios, ensuring consistent data collection, integration, validation, UAT (User Acceptance Training), database lock, and inspection readiness across trials. Set and govern cross-program data strategy as a Clinical Data Manager (Clinical Data Management)/Subject Matter Expert, ensuring consistent standards, conventions, specifications, and change control across studies and systems. Drive program- and portfolio-level quality, risk management, RCA/CAPA, audits, inspections, remediation, and complete, traceable documentation and archival. Lead or sponsor strategic initiatives in data standards, automation, digital enablement, and quality frameworks to improve scalability and efficiency (including but not limited to process, standards, and platform / tools). Represent Global Data Management & Standards in program- and portfolio-level forums; partner with Clinical, Biostatistics and Research Data Science, Global Data Integration and Automation, Global Clinical Data Standards, Safety, IT, service providers, and Global Clinical Trial Operations/ Therapeutic Area leadership to align priorities, risks, budgets, and decisions. Act as the escalation point for complex cross-functional and cross-program issues, providing senior-level decision support and resolution. Support acquisitions and partnerships through data management due diligence and integration oversight, ensuring data quality and compliance when operating outside standard Clinical Data Manager models. Build organizational capability through mentoring, training, playbooks, and communities of practice, developing future Global Data Management & Standards and Program Lead leaders. Establish and use program-level dashboards, KPIs, and analytics to guide execution oversight, service provider engagement, and future deliverables. Govern service provider performance at the program level, including SLAs (Service Level Agreements), KPIs, QBRs (Quarterly Business Reviews), escalations, and remediation planning. People Management responsibilities (as assigned): Set clear objectives aligned to organizational goals; assign work and set priorities. Conduct regular check-ins and annual reviews; coach for performance; provide recognition. Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring. Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR. Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans. Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs. Manage an operating budget and optimize spend against priorities. Align teams around a clear direction; facilitate team/functional meetings. Provide