Associate Director, Clinical Data Management - User Research - Hybrid

Merck; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

Merck in New Jersey seeks an Associate Director, Business System Owner to lead prioritization and delivery of technical solutions, define roadmaps, and govern backlogs to ensure governance and regulatory compliance.

You will partner with Engineering, Architecture, and Product teams to design, test, and deploy scalable, secure integrations while tracking performance and driving continuous optimization. The role requires strong stakeholder management and strategic thinking.

Qualifications

• Extensive experience with SDLC governance and validation activities.
• Experience translating complex business needs into technical deliverables and requirements.
• Familiarity with regulated environments and audit readiness (GxP).
• Strong cross-functional leadership and stakeholder management.

Responsibilities

• Convert complex business processes, data workflows, and integration requirements into clear, actionable technical deliverables and strategic platform recommendations.
• Define and maintain a multi-year product roadmap balancing priorities, innovation, feasibility, scalability, and regulatory compliance.
• Own and govern system backlog and release plans for assigned platforms, aligning with enterprise strategy and compliance controls.
• Partner with Engineering, Architecture, and Product to design, test, and deploy scalable integration solutions meeting end-to-end requirements.
• Supervise intake, prioritization, and evaluation of system enhancements ensuring business value alignment.
• Track performance, analyze release outcomes, identify risks, and drive continuous improvement.
• Facilitate UX and design-thinking workshops to define user needs and solutions.
• Translate user insights into actionable requirements and experience improvements.
• Drive cross-functional ideation and alignment through structured design sessions.

Skills

SDLC Mastery

21 CFR Part 11

URS/FS/DS

API/ETL specs

SQL optimization

Release management

Jira/Confluence/ALM

Design Thinking

Backlog governance

Stakeholder alignment

Tools

Jira

Confluence

ALM

Job description

Job Description

Role Summary:

The Associate Director, Business System Owner leads and oversees the prioritization and delivery of technical solutions. They define roadmaps, manage backlogs, and ensure adherence to governance and regulatory standards.

Responsibilities

Solution delivery:

• Convert complex business processes, data workflows, and integration requirements into clear, actionable technical deliverables and strategic platform recommendations.


• Define and maintain a multi-year product roadmap balancing operational priorities, innovation opportunities, technical feasibility, scalability, and regulatory compliance.


• Own and govern system backlog and release plans for assigned platforms, ensuring alignment with enterprise strategy, functional objectives, and compliance controls.


• Partner with relevant teams (e.g., across Engineering, Architecture, and Product) to design, test, and deploy scalable, secure integration and automation solutions that meet end-to-end business requirements.


• Supervise intake, prioritization, and evaluation of system enhancements, upgrades, and modifications, ensuring alignment with business value and strategic priorities.


• Track performance, analyze release outcomes, identify emerging risks, and drive continuous improvement and long-term optimization.


• Facilitate UX and design-thinking workshops to define user needs and solutions.


• Translate user insights into actionable requirements and experience improvements.


• Drive cross-functional ideation and alignment through structured design sessions.

Business & stakeholder alignment:

• Collaborate with functional leaders to gather, define, document, and prioritize business needs across multiple systems and platforms.


• Facilitate high-impact meetings, workshops, demos, governance discussions, and decision-making forums to ensure alignment and timely progress.


• Define and execute strategies for stakeholder engagement, communications, training, sponsorship, and organizational readiness.


• Contribute to governance forums, workshops, governance sessions, and steering committees, providing insights, decisions, and risk evaluations.


• Drive business case development, benefits assessment, and investment recommendations for new capabilities and platform evolution.

Governance & compliance:

• Lead SDLC, validation, and quality-related activities to ensure release readiness for audits, inspections, and regulatory reviews.


• Apply risk-based decision-making and project management practices to drive optimization, quality, and adherence to internal control standards.


• Ensure data quality, business continuity, and compliance with control frameworks and GxP/audit expectations.


• Develop training materials, onboarding content, and communication plans to support system adoption.

UX & Design Thinking facilitation:

• Facilitate UX and design-thinking workshops to define user needs and solutions.


• Translate user insights into actionable requirements and experience improvements.


• Drive cross-functional ideation and alignment through structured design sessions.

Technical skills:

• Mastery of Software Development Life Cycle (SDLC), deep understanding of CSV (e.g., 21 CFR Part 11, Annex 11) and audit-ready documentation.


• Experience in leading discovery, fit-gap, and config vs. customization; ability to author URS/FS/DS and RTM.


• Ability to interpret API/ETL specs, mappings, and error logs.


• Experience in designing end-to-end cross-system test scenarios.


• Experience working with SQL/query optimization; defining data quality checks; building operational/compliance reports and KPIs.


• Experience with release management in validated environments; ability to ensure audit-ready SOP/WI inputs and evidence.


• Ability to create wireframes/prototypes; facilitate workshops, and document decisions/acceptance criteria.


• Skilled in operating within Scrum/Scaled Agile, with ability to influence backlog prioritization and governance alignment.


• Ability to apply process mining and analytics to identify bottlenecks/variants and drive KPI-based (Key Performance Indicator) optimization.


• Experienced with project management and issue tracking tools (e.g., Jira/Confluence/ALM).


• Ability to connect business outcomes to technical deliverables.

Soft skills:

• Ability to define strategic direction for cross-platform initiatives and align priorities with organizational goals and regulatory expectations.


• Ability to build consensus across senior stakeholders; negotiate competing priorities with diplomacy and enterprise perspective.


• Ability to make informed decisions under ambiguity; balance risk, compliance, and business value.


• Strong communication skills; ability to frame trade-offs and impacts clearly for senior leadership.


• Demonstrate experience mentoring and developing team members; foster a culture of accountability, collaboration, and continuous improvement.


• Ability to navigate high-stakes conversations constructively and resolve conflicts with focus on enterprise outcomes.


• Proficiency in building strong netw