Associate Director, Study Data Services

Job Description

The Associate Director, Study Data Services (M-track) 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.

• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.

Qualifications, Skills & Experience

Technical skills

· Expert-level proficiency in different technology languages (e.g., SQL, Python, SAS, and R) for implementing clinical data collectors, integrations, transformations, visualizations

· Evidence of experience in architecting and interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms

· Proficiency with key data-management and/or clinical operations tools and platforms (e.g., systems for data capture, review, visualization, reconciliation, and reporting), with the ability to help select, configure, or optimize solutions.

· Broad understanding of the data-management technology ecosystem (e.g., data capture, review, reconciliation, reporting, analytics, and enabling tools) and how components fit together across the end-to-end process.

· Experience leveraging automation, scripting, or digital solutions to streamline data-management activities and reduce manual effort.

· Ability to interpret operational and quality metrics, use analytical/forecasting tools for capacity and scenario planning, and translate insights into clear decisions and actions.

· Strong understanding of common clinical and regulatory data standards, clinical operational data models, metadata management, and controlled terminologies (e.g., MedDRA, WHODrug) to ensure consistency and submission readiness.

· Strong understanding of validation, system lifecycle, data-privacy, and System Development Lifecycle Management activities

· Strong understanding of drug discovery process, FDA regulations, GxP / ICH guidelines

· Ability to connect business outcomes to technical deliverables

Non-technical skills

· Strong ability to lead teams in a matrixed, global organization while ensuring delivery excellence through effective problem-solving techniques

· Demonstrated success in coaching, developing, and performance-managing high-performing individuals

· Builds strong partnerships across technical, business, and quality functions to enhance collaboration and deliver integrated outcomes

· Balances business needs, resource capacity, and compliance requirements to make sound operational decisions

· Capable of leading teams through process and organizational transformation with empathy and clarity

Enterprise Leadership Skills

· Execution Excellence | Is results-focused per compliance standards; sets ambitious expectations for accomplishment and ensures others contribute to org strategies by focusing them on the most critical priorities; translates departmental goals into clear expectations

· Coaching and Development | Manages individual contributors and/or supervisors, provides technical guidance, and develops others through coaching, feedback, and guidance

· Entrepreneurship | Embraces patient customer focus, ensuring that internal or external customer perspective is the driving force behind strategic priorities, business decisions, org processes, and individual activities; crafts and implements service practices that meet customers' and own organization needs

Qualifications & experience

Non-Degree or Associate's Degree with a minimum of 10 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations function, and:

• 2 years of people management experience.

• Demonstrated deep subject matter expertise in clinical development.

OR

Bachelor's Degree with a minimum of 8 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations function, and:

• 2 years of people management experience.

• Demonstrated deep subject matter expertise in clinical development.

OR

Advanced Degree (Masters or Doctorate) with a minimum of 4 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations functions, and:

• 2 years of people management experience.

Demonstrated deep subject matter expertise in clinical development.

Additional location(s) Compensation Information:

Required Skills

• Adaptability, Clinical Data Management, Clinical Trials, Data Analysis, Data Extraction, Data Integration, Data Validation, Decision Making, Good Clinical Practice (GCP), Interpersonal Relationships, People Leadership, Pharmacovigilance, PL/SQL (Programming Language), Regulatory Compliance, Strategic Thinking

Preferred Skills:

• Current Employees apply HERE

• Current Contingent Workers apply HERE

• Search Firm Representatives Please Read Carefully

• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

• Regular

Relocation:

• No relocation

VISA Sponsorship:

• No

Travel Requirements:

• No Travel Required

Flexible Work Arrangements:

• Hybrid

Shift:

• Not Indicated

Valid Driving License:

• No

Hazardous Material(s):

• N/A

Job Posting End Date:

• 10/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.