Director, Study Data Services (Hybrid)

Location: USA - New Jersey - Rahway

The Director, Study Data Services (M-track) leads programming and reporting strategy and delivery across therapeutic areas underneath leadership, ensuring scalable standards, audit-ready execution, and regulatory-compliant outcomes across complex studies and initiatives. This role builds critical programming capabilities and drives automation and emerging technologies to improve efficiency, quality, and data integrity. The Director also manages service provider partnerships and develops high-performing teams through clear direction, coaching, and change leadership.

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.

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.
• Inspire and ensure that team leaders are effectively supporting and empowering their team.
• 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 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 skills with the ability to align diverse, multi-country/cross-functional teams and stakeholders around shared objectives.
• Distill complex issues into decision-ready narratives; frame options, risks, and recommendations to influence senior decisions.
• Exceptional stakeholder management and negotiation skills, with the ability to influence across functions and seniority levels.
• Resilient and adaptable, with a balance of strategic vision and operational execution.
• Change leadership, influencing across executive stakeholders.
• Ability to integrate business, operational, and people dimension into decision-making.
• Align senior stakeholders on objectives, interfaces, and responsibilities; enforce clean handoffs and resolves conflicts.
• Ability to coordinate decisions across regions / time zones; use asynchronous mechanisms to maintain momentum.
• Drive adoption of standardized methods/ways of working; mobilize cross-functional champions and measures uptake.
• Engage service providers, leadership, and industry forums; represent team professionally and credibly under pressure; maintain resilience and composure.
• Ability to define and execute organizational strategy for operations across regions.
• Demonstrated success managing large, diverse, and geographically distributed teams.
• Strong understanding of operational, financial, and compliance dimensions of global data delivery.
• Capable of leading transformation initiatives and fostering innovation across complex organizations.
• Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction.
• Lead through influence across functions/geographies; mentor global cohorts; provide structured feedback.

Enterprise Leadership Skills

Strategic Planning | Plan strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commit to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.

Networking and Partnerships | Cultivate networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.

Change Catalyst | Lead change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyze new approaches to improve results by evolving culture, systems, and services; help others overcome resistance and adopt change.

Qualifications & experience

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

OR

• 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:
• 3 years of 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

Enterprise Leadership, Leadership, Strategic Vision

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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