Associate Director, Study Data Services

Merck & Co.; Rahway (NJ); In loco; USD 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Merck & Co. is seeking an Associate Director, Study Data Services to lead a programming and reporting team, set goals, coach performance, and manage onboarding while communicating status and risks to leadership and partners.

The role provides hands-on technical review, enforces SOPs and standards, manages workload and timelines, drives best practices, continuous improvement, and partners with GDMS to deliver high-quality, coordinated data solutions across portfolios.

Competenze

• Experience leading programming and reporting teams in a clinical setting.
• Strong data integration and data modeling capabilities.
• Proven ability to enforce SOPs/standards and drive continuous improvement.
• Ability to translate strategy into actionable roadmaps and priorities.

Mansioni

• Lead design and deployment of clinical technology system solutions (EDC, RTSM, 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 design, build, and validation processes.
• Apply data literacy to design transformation strategies for actionable insights.
• Develop advanced reporting solutions 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 for reliability.
• Automate and strengthen data engineering processes to reduce risk and improve efficiency.
• Develop robust data models, semantic layers, and curated datasets; enforce quality checks.
• Drive process optimization by identifying gaps and implementing improvements.
• Translate strategy into clear priorities, roadmaps, and ways of working for assigned domains.
• Lead testing strategies for solutions; automate validation and ensure traceability.
• Contribute to resource planning and workload distribution across global teams.
• Set documentation and audit standards; ensure compliance through rigorous change management.
• Lead cross-functional collaboration, meetings, and enterprise-level improvement programs.
• Influence adoption of data standards, tools, and automation for better delivery and decision-making.
• Provide leadership, coaching, and mentoring to build capabilities and foster a culture of quality and collaboration.
• Support release management across environments; align stakeholders, lead UAT, and improve reporting standards.
• Partner across teams to turn data and technical findings into clear, actionable recommendations
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.

Conoscenze

Team leadership

Coaching

Clinical data programming

Data integration

SOPs and standards

Automation and QA

Strumenti

EDC Systems

RTSM

eCOA/ePRO

Descrizione del lavoro

Job Description

Role Overview

The Associate Director, Study Data Services leads and develops a programming and reporting team - set goals, assign work, coach performance, and manage recruiting/onboarding - while communicating status and risks to leadership and partners. Provide hands-on technical review, solutioning support, enforce SOPs/standards, manage workload and prioritization, track quality and timelines, and drive best practices (code review, reusable components, test automation) and continuous improvement.

Responsibilities

Programming and reporting

• Lead design and deployment of clinical technology system solutions (e.g., for EDC [Electronic Data Capture], RTSM [Randomization and Trial Supply Management], and eCOA/ePRO [electronic Clinical Outcomes Assessment/ electronic Patient-Reported Outcomes]) 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.
• Apply data literacy to design transformation strategies for actionable insights.
• Develop advanced reporting solutions (dashboards, listings, visual analytics) with reusable components and role-based access.

Data Engineering

• 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 for reliability.
• Automate and strengthen data engineering processes to reduce risk and improve efficiency.
• Develop robust data models, semantic layers, and curated datasets; enforce quality checks.

Process

• Drive process optimization by identifying gaps and implementing improvements.
• Translate strategy into clear priorities, roadmaps, and ways of working for assigned domains.
• Lead testing strategies for solutions; automate validation and ensure traceability.
• Contribute to resource planning and workload distribution across global teams.
• Set documentation and audit standards; ensure compliance through rigorous change management.
• Lead cross-functional collaboration, meetings, and enterprise-level improvement programs.
• Influence adoption of data standards, tools, and automation for better delivery and decision-making.
• Provide leadership, coaching, and mentoring to build capabilities and foster a culture of quality and collaboration.
• Support release management across environments; align stakeholders, lead UAT (User Acceptance Training), and improve reporting standards.
• Partner across teams to turn data and technical findings into clear, actionable recommendations
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.

People management

• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Coordinate onshore/offshore and contingent resources; ensure role clarity