Associate Director, Study Data Services (M-track)

About the role

The Associate Director, Study Data Services (M-track) leads and develops a programming and reporting team, setting goals, assigning work, coaching performance and managing recruiting and onboarding, while keeping leadership and partners informed of status and risks. The role covers hands-on technical review, solutioning support, enforcement of SOPs and standards, workload management, quality tracking and continuous improvement.

Key responsibilities

• Lead design and deployment of clinical technology solutions such as EDC, RTSM and eCOA/ePRO, and provide technical oversight of clinical programming, reporting and data integration
• Define and govern integration architecture, data models, semantic layers and curated datasets, and monitor data ingestion and consumption
• Drive process optimization, testing strategies, release management, UAT and audit standards, and lead cross-functional collaboration and improvement programs
• Manage the team: set objectives, run check-ins and annual reviews, coach performance, develop career plans, lead recruiting and hiring, coordinate on-shore/off-shore and contingent resources, and manage an operating budget

Required profile

• Non-degree or Associate's degree with at least 10 years in clinical data programming, data engineering or related functions, including 2 years of people management and deep clinical development expertise
• Bachelor's degree with at least 8 years in the same fields, including 2 years of people management and deep clinical development expertise
• Advanced degree (Master's or Doctorate) with at least 4 years in the same fields, including 2 years of people management and deep clinical development expertise

Required skills

• Expert-level proficiency in SQL, Python, SAS and R
• Experience architecting EDC platforms, data integration environments, clinical operations systems and cloud platforms
• Proficiency with data-management and clinical operations tools, and automation and scripting to reduce manual effort
• Understanding of clinical and regulatory data standards (MedDRA, WHODrug), validation, GxP/ICH guidelines, FDA regulations and the drug discovery process
• Strong leadership, coaching and partnership skills in a matrixed, global organization