Associate Director Program Data Delivery

Role Description:

The Associate Director, Program Data Delivery provides program-level leadership in complex programs and will be accountable for ensuring high-quality, inspection-ready data across studies and programs as needed , driving alignment, consistency, standardization, scalability, and innovation from study planning through database lock.

This role leads and mentors a pod of Data Delivery Leads and Central Monitors ensuring standardized, scalable, and inspection-ready delivery across the portfolio.

The Associate Director serves as the strategic Data Management leader, responsible for shaping delivery models within a therapeutic area, influencing cross-functional decisions, and driving continuous improvement and innovation across programs.

STRATEGIC PILLAR

• Define and drive Data Delivery strategy at the program level, aligned to GDO priorities
• Shape and evolve operating models for Program Data Delivery and Central Monitoring, including monitoring of resource needs, governance, and delivery frameworks
• Lead standardization and modernization initiatives (e.g., integrated data review approach, risk-based data management, advanced automation, etc.) across programs
• Influence portfolio prioritization, risk trade-offs, and execution strategies in partnership with Clinical Operations, Biostatistics,Safety, and Medical Monitoring
• Represent Data Management in senior governance forums, providing strategic insights and recommendations
• Build sustainable and scalable capability models (talent, tools, and processes) to support portfolio growth

Roles Responsibilities:

Portfolio Program Delivery Oversight

• Accountable for end-to-end delivery of high-quality, inspection-ready clinical data across multiple programs, ensuring adherence to timelines, regulatory requirements, and quality standards, while driving consistent database readiness, data cleaning, reconciliation, and seamless database lock execution.
• Drive program-level adoption and cross-study standardization of data management practices - including DMP, IDRP, query management, and reconciliationto improve efficiency, consistency, and scalability across programs
• Manage inter-study dependencies, timelines, and critical paths to ensure seamless program execution and delivery alignment
• Drive adoption of advanced analytics, automation, and AI-enabled data review to enhance data quality, efficiency, and insight generation
• Ensure continuous inspection readiness and proactively support regulatory inspections and audits

Leadership of Program Data Delivery Central Monitoring

• Lead pods of Data Delivery Leads, and Central Monitors and mentor Program Data Delivery Leads
• Drive consistent execution through clear expectations and performance accountability
• Build leadership capability and pipeline through mentorship and development
• Ensure effective central monitoring for early risk detection

Risk Management Governance

• Own portfolio-level risk strategy, including identification, escalation, and mitigation
• Translate program risks into portfolio insights and proactive actions
• Lead governance forums and drive resolution of complex cross-functional issues
• Serve as escalation point for critical data delivery risks

Metrics, Insights Decision Support

• Oversee key program metrics, ensuring timely actions, resolution, and closure of identified issues
• Leverage analytics to identify trends, risks, and improvement opportunities across programs
• Provide clear, actionable portfolio insights to senior leadership, enabling informed, data-driven decisions and effective trade-off management

Cross-Functional Vendor Leadership

• Influence across Clinical Operations, Biostatistics, Safety, Systems, and vendors
• Align program execution with portfolio and enterprise priorities
• Oversee vendor performance and delivery quality at scale

Process Excellence Transformation

• Drive adoption of standardized methodologies and best practices
• Lead improvements to enhance efficiency, scalability, and quality
• Champion innovation in central monitoring and data review

Basic Qualifications and Experience:

• Doctorate /Masters Degree /bachelors degree with 15+ years of experience in life sciences / clinical data management
• Proven experience leading programs/portfolios in clinical data management
• Demonstrated people leadership and organizational management experience.

Preferred Experience:

• 15+ years work experience in life sciences or medically related field, including 10 years of managing data on biopharmaceutical clinical research experience
• Extensive experience in Program Data Delivery and Central Monitoring models
• Strong experience in portfolio oversight across multiple global clinical trials
• Demonstrated ability to operate at both strategic and execution levels
• Experience influencing in matrixed, global environments
• Experience leading teams, transformation and modernization initiatives
• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
• Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)
• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management.

Functional Competencies:

Must-Have Competencies:

• Ability to lead portfolio-scale delivery and influence enterprise-level decisions
• Strong capability to identify cross-program risks and drive mitigation strategies
• Expertise in interpreting complex clinical and operational data to guide portfolio execution
• Ability to drive standardization, scalability, and innovation across programs
• Proven ability to build, develop, and lead high-performing teams across geographies
• Strong experience managing vendors and cross-functional dependencies at scale
• Ability to drive change and adoption of new operating models across the organization

Soft Skills:

• Strong executive presence and communication skills
• Ability to influence senior leadership and cross-functional stakeholders
• Strategic thinking combined with strong execution orientation