Associate Director, Study Data Services

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 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.

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, as well as:

• 2 years 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, as well as:

• 2 years 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, as well as:

• 2 years people management experience.

• Demonstrated deep subject matter expertise in clinical development.

#eligibleforERP

#clinicaltrialjobs

Required Skills:

Clinical Data Management, Data Integrity, Data Management, Decision Making, Good Clinical Data Management Practice (GCDMP), Organizational Leadership, People Leadership, Stakeholder Management, Strategic Thinking, Team Leadership

Preferred Skills:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/10/2026

*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.

Requisition ID: R424613