Associate Director, Study Data Services

Merck•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 while providing hands-on technical review and solutioning support. It enforces SOPs and standards, manages workload and prioritization, tracks quality and timelines, and drives best practices and continuous improvement. The position provides technical leadership for clinical programming, reporting, data integration, and data engineering across portfolios. It leads the design and deployment of clinical technology solutions, governs integration architecture and standards, develops reporting solutions and curated datasets, and strengthens automation, testing, quality, and validation. The role also supports release management, UAT, documentation, audit readiness, and regulatory compliance. As a people leader, the Associate Director aligns teams with organizational goals, manages performance and development, coordinates onshore, offshore, and contingent resources, and manages operating budgets. The role leads cross-functional collaboration and enterprise improvement efforts, building partnerships and translating data and technical findings into actionable recommendations. The position is based in Rahway, New Jersey, with a hybrid work arrangement.

Requirements

At least 10 years of experience in clinical data programming, data engineering, or a related data-management or clinical operations function with a non-degree or associate's degree, plus at least 2 years of people management experience and deep subject matter expertise in clinical development; OR
At least 8 years of experience in clinical data programming, data engineering, or a related data-management or clinical operations function with a bachelor's degree, plus at least 2 years of people management experience and deep subject matter expertise in clinical development; OR
At least 4 years of experience in clinical data programming, data engineering, or a related data-management or clinical operations function with a master's or doctoral degree, plus at least 2 years of people management experience and deep subject matter expertise in clinical development.
Expert-level proficiency in technology languages such as SQL, Python, SAS, and R for clinical data collectors, integrations, transformations, and visualizations.
Experience architecting and supporting interoperability among EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms.
Proficiency with data-management and/or clinical operations platforms 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 translate 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 ensure delivery excellence using effective problem-solving techniques.
Demonstrated success coaching, developing, and performance-managing high-performing individuals.
Ability to build partnerships across technical, business, and quality functions to enhance collaboration and deliver integrated outcomes.
Ability to balance business needs, resource capacity, and compliance requirements when making operational decisions.
Ability to lead teams through process and organizational transformation with empathy and clarity.
Execution excellence: focus on results and compliance, establish ambitious expectations, focus teams on critical priorities, and translate departmental goals into clear expectations.
Coaching and development: manage individual contributors and/or supervisors, provide technical guidance, and develop others through coaching and feedback.
Entrepreneurship: maintain a patient and customer focus and develop service practices that meet customer and organizational needs.

Responsibilities

Lead and develop the programming and reporting team by setting goals, assigning work, coaching performance, and managing recruiting and onboarding.
Communicate project status and risks to leadership and partners, and provide hands-on technical review and solutioning support.
Enforce SOPs and standards; manage workload and priorities; track quality and timelines; and promote code review, reusable components, test automation, and continuous improvement.
Lead the design and deployment of clinical technology system solutions, including EDC, RTSM, and eCOA/ePRO solutions, using programming frameworks and automation tools.
Provide technical oversight for clinical programming, reporting, and data integration across portfolios.
Recommend and implement tools to streamline design, build, and validation processes, and apply data literacy to develop transformation strategies for actionable insights.
Develop advanced dashboards, listings, and visual analytics with reusable components and role-based access.
Define and govern 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, and develop robust data models, semantic layers, curated datasets, and quality checks.
Drive process optimization, translate strategy into priorities and roadmaps, lead 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, and influence adoption of data standards, tools, and automation.
Provide leadership, coaching, and mentoring; support release management across environments; align stakeholders; lead UAT; and improve reporting standards.
Partner across teams, including GDMS, to translate data and technical findings into recommendations, align priorities, seek input, and close feedback loops.
Align teams around clear direction and objectives, assign work and priorities with sustainable work-life balance in mind, and conduct check-ins and annual reviews.
Develop career plans, create growth opportunities and promotion cases, and ensure appropriate training and mentoring.
Coordinate onshore, offshore, and contingent resources; ensure role clarity and effective handoffs; manage an operating budget and optimize spending.
Ensure team leaders effectively support and empower their individual leaders.