Associate Director, Study Data Services

MSD•Rahway, NJ

2d•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 priorities, tracks quality and timelines, and advances best practices and continuous improvement. The position provides technical and people leadership across clinical programming, reporting, data integration, and data engineering. It leads the design and deployment of clinical technology solutions, including EDC, RTSM, and eCOA/ePRO systems; develops reporting solutions and reusable assets; defines integration architecture and data models; and strengthens data ingestion, transformation, validation, and quality processes. The role also drives process optimization, testing strategies, release management, audit-ready documentation, resource planning, and cross-functional collaboration. As a people leader, the Associate Director aligns teams to organizational goals, manages performance and development, coordinates onshore, offshore, and contingent resources, and manages an operating budget. The role partners across technical, business, quality, and clinical functions to translate data and technical findings into actionable recommendations and ensure high-quality, coordinated delivery.

Requirements

At least 2 years of people management experience.
Demonstrated deep subject matter expertise in clinical development.
Meet one of the stated education and experience pathways: non-degree or associate degree with at least 10 years of relevant experience; bachelor's degree with at least 8 years; or advanced degree (master's or doctorate) with at least 4 years.
Relevant experience must be in clinical data programming, data engineering, or a related data-management or clinical operations function.
Expert-level proficiency in technology languages such as SQL, Python, SAS, and R for clinical data collection, integration, transformation, and visualization.
Experience architecting and integrating 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 select, configure, or optimize solutions.
Broad understanding of the data-management technology ecosystem and how its components fit together across the end-to-end process.
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 deliver effectively through 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 when making operational decisions.
Ability to lead teams through process and organizational transformation with empathy and clarity.
Demonstrated execution excellence, including setting ambitious expectations, focusing teams on critical priorities, and translating departmental goals into clear expectations.
Ability to manage individual contributors and/or supervisors, provide technical guidance, and develop others through coaching and feedback.
Customer-focused approach to strategic priorities, business decisions, organizational processes, and service practices.
Required skills include Clinical Data Management, Data Integrity, Data Management, Decision Making, Good Clinical Data Management Practice (GCDMP), Organizational Leadership, People Leadership, Stakeholder Management, Strategic Thinking, and Team Leadership.

Responsibilities

Lead, develop, and organize the programming and reporting team by setting goals, assigning work, managing recruiting and onboarding, coaching performance, and communicating status and risks.
Provide hands-on technical review and solutioning support; enforce SOPs and standards; manage workload, priorities, quality, and timelines.
Drive best practices and continuous improvement, including code review, reusable components, and test automation.
Lead the design and deployment of clinical technology system solutions, including EDC, RTSM, and eCOA/ePRO, using programming frameworks and automation tools.
Provide technical oversight for clinical programming, reporting, and data integration across portfolios.
Recommend and implement tools to streamline solution design, build, and validation processes.
Develop advanced reporting solutions, including dashboards, listings, and visual analytics, using reusable components and role-based access.
Define and govern integration architecture, data sources, and transformation workflows; ensure consistent use of enterprise standards and reusable assets.
Monitor and troubleshoot data ingestion and consumption; automate and strengthen data engineering processes to improve reliability, reduce risk, and increase efficiency.
Develop data models, semantic layers, and curated datasets, and enforce data quality checks.
Identify process gaps and implement improvements; translate strategy into priorities, roadmaps, and ways of working for assigned domains.
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 rigorous change management.
Lead cross-functional collaboration, meetings, and enterprise-level improvement programs.
Influence adoption of data standards, tools, and automation to improve delivery and decision-making.
Support release management across environments, align stakeholders, lead UAT, and improve reporting standards.
Partner with GDMS and other cross-functional teams to align priorities, seek input, close feedback loops, and deliver coordinated work.
Set clear team objectives aligned with organizational goals, assign work and priorities while considering sustainable work-life balance, and conduct check-ins and annual reviews.
Recognize and coach employees, develop career plans and growth opportunities, prepare promotion cases, and ensure appropriate training and mentoring.
Coordinate onshore, offshore, and contingent resources and ensure role clarity and effective handoffs.
Manage an operating budget and optimize spending against priorities.
Support and empower team leaders and their individual teams.
Apply data literacy to design transformation strategies that produce actionable insights and turn data and technical findings into clear recommendations.