Associate Director, Clinical Data Management - User Research - Hybrid

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 networks across key stakeholders (e.g., IT, QA, Operations, and vendors)
• Ability to engage with external industry forums, working groups and peers to assess capabilities and bring back best practices to elevate enterprise standards and modernization efforts.
Enterprise Leadership Skills:

• Innovation
• - Apply creative courage, proactively confront difficult issues, be willing to offer creative alternatives and recommend improvements based on business challenges; able to challenge status quo and handle pushback
• .
• Strategic Planning
• - Guide team success; use appropriate methods and a flexible interpersonal style to build and guide cohesive team to complete shared goals; prioritize and plan; establish an action plan with clear timelines and resources; orchestrate complex work and align multiple stakeholders
• .
• Influence
• - Provide expertise across multiple areas and lead project teams without formal authority; persuade others to adopt improvements and align around project approaches and priorities.
Qualifications & experience:

• Non-Degree or Associate's Degree with a minimum of 10 years' experience in one or more of the following areas relevant to the job: Business system ownership, product owner, project and business lead or SDLC/Agile delivery.
OR
• Bachelor's Degree with a minimum of 8 years' experience in one or more of the following areas relevant to the job: Business system ownership, product owner, project and business lead or SDLC/Agile delivery.
OR
• Advanced Degree (Masters or Doctorate) with a minimum of 4 years' experience working in one or more of the following areas relevant to the job: Business system ownership, product ownership or SDLC/Agile delivery.
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EligibleforERP

#GDMS

Required Skills:
Backlog Prioritization, Design Thinking, Detail-Oriented, Issue Tracking, Process Mining, Project Management Tools, Regulatory Compliance, Software Development Life Cycle (SDLC), Strategic Thinking, Wireframing

Preferred Skills:
Clinical Data Management, Influencing Skills

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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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 .

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
11/18/2026
*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: R426133