Associate Director, Study Data Services
- Location
- CRI - San Jose - San Jose (City Place)
- Work mode
- On-site
- Employment type
- Full-time
About the job
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 need s
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:
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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.
From Merck's careers page (Workday), checked 29 Oct 2026.
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Posted 19 Oct 2026 · checked 29 Oct 2026 · Report this job