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., 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.

Dataflow Metadata AWS Glue Timelines Operations Leadership Management Automation Mentorship Governance Innovation Resilience Compassion Databricks Code Review Scalability Negotiation Forecasting Digital Data Adaptability Disabilities Data Privacy Collaboration Prioritization SAS (Software) Data Integrity Data Reporting Drug Discovery System Testing Clinical Trials Test Automation FDA Regulations Problem Solving Data Management Cloud Computing Data Validation Data Integration Machine Learning Telephone Skills Data Engineering Interoperability Project Delivery Change Management Data Architecture Growth Strategies Influencing Skills Strategic Planning Advanced Analytics Azure Data Factory Data Virtualization Contingent Workforce Strategic Leadership Regulatory Compliance Programming Languages Emerging Technologies Global Delivery Model Stakeholder Management IT Capacity Management Artificial Intelligence Pre-Clinical Development Clinical Data Management R (Programming Language) Software Technical Review SQL (Programming Language) Python (Programming Language) Electronic Data Capture (EDC) Continuous Improvement Process Systems Development Life Cycle

At least 10 years, * 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, * 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

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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

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.