Director, Study Data Services (Hybrid)

Location: USA - New Jersey - Rahway

Job Summary

The Director, Data Architect (P-track) works with leadership to define and execute the long-term programming strategy for integration, automation, and analytics across therapeutic areas; establish enterprise standards, and champions continuous improvement. Manage service providers and complex multi-project delivery to full compliance; drive AI/ML and analytics initiatives, provide deep subject matter expertise, shape the DI&A capability roadmap, and plan capacity and competency growth.

Provide hands-on technical review, 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

• Work with leadership to define and execute the long-term programming and reporting strategy for data integration, reporting, automation, and analytics enablement across therapeutic areas
• Establish and continuously improve programming and reporting standards, frameworks, and operating models anticipating compliance and operational risks to drive scalability, consistency, and strategic outcomes
• Manage service provider partnerships, ensuring adherence to enterprise processes, audit readiness, and quality benchmarks
• Oversee programming and reporting delivery across multiple, highly complex studies / projects; ensuring accuracy, efficiency, and full regulatory compliance
• Provide deep subject matter expertise on programming and reporting strategies, data engineering, and data flow across clinical data systems on more complex studies/ protocols or special projects
• Work with DI&A leadership to help them set strategy for programming and reporting capabilities to be built by DI&A
• Collaborate with senior leadership on long-term capacity planning and competency growth strategies for Data Architects

Data Engineering

• Own development of critical capabilities (tools, processes, skills) aligned to industry best practices.
• Champion adoption of automation, continuous improvement, and metadata-driven development to enhance productivity and data integrity
• Drive initiatives that leverage emerging technologies (AI/ML, advanced analytics, data virtualization) to enhance data review and reporting efficiency

Process

• Actively work to solve unique operational challenges with broad organizational impact through direct engagement, facilitation, mentoring, and expert problem-solving techniques.
• Evaluate and implement process/technology improvements that enhance scalability, standardization, and quality; support evolving operating model adoption.
• Partner across teams to translate data and complex technical insights into strategic, actionable outcomes
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning priorities, and closing feedback loops to drive high-quality, coordinated delivery.

Technical skills

• Expert-level proficiency in different programming languages (e.g., Python, R, SAS, SQL) for implementing clinical data collectors, integrations, transformations, visualizations
• Expert knowledge of standards and enterprise data management principles, with the ability to set standards for integration, reuse, and scalability.
• Expert in the interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms
• Experience designing or managing cloud-based pipelines (e.g., Azure Data Factory, AWS Glue, Databricks).
• Demonstrated success in managing outsourced programming operations and global delivery partners
• Deep understanding of end-to-end data management governance, clinical operations, operational metrics, and quality frameworks.
• Proven track record implementing risk-based and digital data practices across regions/multiple regions.
• Advanced use of analytical and forecasting tools to inform capacity and operational decisions.
• Oversee regional risk, escalation, and capacity management processes; ensure compliance with local business and labor regulations.
• Operating knowledge of SDLC/CSV, data privacy, and inspection-readiness requirements to govern change at enterprise scale.
• Deep knowledge of drug discovery process, FDA regulations, GxP / ICH guidelines
• Ability to connect business outcomes to technical deliverables

Soft skills

• Strategic leadership with the ability to align, multi-country / cross-functional teams and stakeholders around shared objectives.
• Strong people leadership, mentoring, and development capabilities across multiple levels and geographies.
• Advanced stakeholder management and negotiation skills, with the ability to influence across functions and seniority levels.
• Ability to lead change, embed innovation, and drive continuous improvement initiatives.
• Resilient and adaptable, with a balance of strategic vision and operational execution.
• Ability to integrate business, operational, and people dimensions into decision-making.
• Able to engage in service providers, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure.

Enterprise Leadership Skills

Business Savviness | Anticipate business and regulatory issues and shape strategy accordingly; connect technical expertise to organizational and industry context to make strategic recommendations

Influence | Lead large teams / projects, help shape departmental strategy, influence leaders, peers, and cross-functional partners to align on decisions and strategic direction

Change Catalyst | Drive improvements (e.g., organizational and cultural changes) with broader impact; demonstrate adaptability and ability to collaborate with others to make change successful; help others overcome resistance to change

Qualifications & experience

Bachelor's Degree with a minimum of 10 years’ experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions, as well as:Demonstrated deep subject matter expertise in clinical development.

Advanced Degree (Masters or Doctorate) with a minimum of 8 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions, as well as demonstrated deep subject matter expertise in clinical development.

#eligibleforERP

#clinicaltrialjobs

Required Skills

Change Management, Clinical Data Management, Clinical Study Protocols, Data Management, Data Reporting, Data Validation, Delivery Management, Regulatory Compliance, Stakeholder Management, Strategic Leadership

Preferred Skills

Deliverables Management, End-to-End Testing, Operational Decisions

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

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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:

$173,200.00 - $272,600.00

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

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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

Domestic

VISA Sponsorship

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/22/2026

*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.

Additional Locations: USA - Pennsylvania - Upper Gwynedd