Associate Director, Study Data Services

MSD • Rahway, NJ

3d • $142,400 - $224,100 • Hybrid

About The Position

The Associate Director, Study Data Services leads and develops a programming and reporting team, setting goals, assigning work, coaching performance, and managing recruiting and onboarding. The role communicates status and risks to leadership and partners, provides hands-on technical review and solutioning support, enforces SOPs and standards, manages workload and prioritization, tracks quality and timelines, and advances best practices and continuous improvement.

The position provides technical oversight for clinical programming, reporting, data integration, and data engineering across portfolios. It leads the design and deployment of clinical technology solutions, including systems such as EDC, RTSM, and eCOA/ePRO; develops reporting solutions and reusable data assets; governs integration architecture and data workflows; and automates processes to strengthen reliability, quality, and efficiency.

The Associate Director translates strategy into priorities and roadmaps, leads testing and release activities, maintains documentation and audit standards, supports resource planning and budget management, and drives cross-functional collaboration and process improvement. The role also manages and develops employees and team leaders, coordinates onshore, offshore, and contingent resources, and partners with GDMS and other teams to deliver coordinated, actionable outcomes.

The position requires deep clinical development subject matter expertise, strong clinical data programming or data engineering experience, and at least two years of people-management experience. The required experience threshold varies by education: 10 years for a non-degree or associate’s degree, 8 years for a bachelor’s degree, or 4 years for an advanced degree. The position is hybrid and located primarily in Rahway, New Jersey. The listed base salary range for the primary location is $142,400 to $224,100, and the successful candidate is eligible for an annual bonus and long-term incentive, if applicable.

Requirements

• At least two years of people-management experience.
• Demonstrated deep subject matter expertise in clinical development.
• Experience in clinical data programming, data engineering, or a related data-management or clinical operations function: 10 years with a non-degree or associate’s degree; 8 years with a bachelor’s degree; or 4 years with an advanced degree (master’s or doctorate).
• Expert-level proficiency in technology languages such as SQL, Python, SAS, and R for clinical data collection, integrations, transformations, and visualizations.
• Experience architecting and enabling interoperability across EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms.
• Proficiency with data-management and/or clinical operations tools for data capture, review, visualization, reconciliation, and reporting, including the ability to help select, configure, or optimize solutions.
• Broad understanding of the data-management technology ecosystem and how its components fit together across end-to-end processes.
• Experience using automation, scripting, or digital solutions to streamline data-management activities and reduce manual effort.
• Ability to interpret operational and quality metrics, use analytical or forecasting tools for capacity and scenario planning, and turn insights into decisions and actions.
• Strong understanding of clinical and regulatory data standards, clinical operational data models, metadata management, and controlled terminologies such as MedDRA and WHODrug.
• Strong understanding of validation, system lifecycle, data privacy, and System Development Lifecycle Management activities.
• Strong understanding of drug discovery, FDA regulations, and GxP/ICH guidelines.
• Ability to connect business outcomes to technical deliverables.
• Ability to lead teams in a matrixed, global organization and deliver through effective problem-solving.
• Demonstrated success coaching, developing, and performance-managing high-performing individuals.
• Ability to build partnerships across technical, business, and quality functions.
• Ability to balance business needs, resource capacity, and compliance requirements in operational decisions.
• Ability to lead teams through process and organizational transformation with empathy and clarity.
• Leadership capabilities in execution excellence, coaching and development, and entrepreneurship, including customer-focused service practices.

Responsibilities

• Lead and develop a programming and reporting team, including setting goals, assigning work, coaching performance, and managing recruiting and onboarding.
• Communicate status, risks, and priorities to leadership and business partners.
• Provide hands-on technical review and solutioning support; enforce SOPs and standards; manage workload and prioritization; track quality and timelines.
• Lead design and deployment of clinical technology solutions, including EDC, RTSM, and eCOA/ePRO systems, using programming frameworks and automation tools.
• Provide technical oversight for clinical programming, reporting, and data integration across portfolios.
• Recommend and implement tools that streamline solution design, development, and validation.
• Develop advanced reporting solutions such as dashboards, listings, and visual analytics using reusable components and role-based access.
• Define and govern data integration architecture, including data sources and transformation workflows.
• Ensure consistent implementation of enterprise standards and reusable assets; monitor and troubleshoot data ingestion and consumption.
• Automate and strengthen data engineering processes, develop data models and curated datasets, and enforce quality checks.
• Identify process gaps and implement improvements; translate strategy into priorities, roadmaps, and ways of working.
• Lead solution testing strategies, automate validation, and ensure traceability.
• Contribute to resource planning and workload distribution across global teams.
• Set documentation and audit standards and ensure compliance through change management.
• Lead cross-functional collaboration, meetings, and enterprise improvement programs; influence adoption of data standards, tools, and automation.
• Provide leadership, coaching, and mentoring to build team capabilities and a culture of quality and collaboration.
• Support release management across environments, align stakeholders, lead UAT, and improve reporting standards.
• Partner with teams to translate data and technical findings into actionable recommendations; work with GDMS and other teams to align priorities and close feedback loops.
• Align teams around clear direction and organizational goals; set objectives, assign work, and set priorities that account for sustainable work-life balance.
• Conduct regular check-ins and annual reviews, coach for performance, provide recognition, develop career plans, and create growth and training opportunities.
• Coordinate onshore, offshore, and contingent resources and ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spending against priorities.
• Ensure team leaders effectively support and empower their individual leaders.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed