Associate Director, Clinical Data Management - User Research - Hybrid

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

• 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.
• 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.
• 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.

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 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.