Director, Clinical Data Management, Global Data Management and Standards

Job Description The Director, Data Collection Data Steward (M-track) leads teams that create, maintain, and govern clinical data standards and libraries end-to-end, acting as escalation point for complex governance and ensuring quality and consistency across systems (e.g., Veeva), resourcing, and portfolio prioritization. Partner across functions on metrics, risk, and industry engagement while leading training strategy and departmental initiatives.

• Accountable for oversight of teams defining and maintaining standard data collection (EDC [Electronic Data Capture and non-EDC modalities) definitions aligned with industry standards (e.g., CDISC [Clinical Data Interchange Standards Consortium]) and Health Authority regulations and guidance; working with DCDS (Data Collection Data Steward) team members to ensure harmonization across clinical lifecycle and across studies.
• Identify opportunities, leads, or participates in organizational initiatives as needed.
• Support audits and inspections as required.
• Participate in defining and maintaining the governance model for clinical data standards (e.g., define forum purposes & scope, decision rights, and escalation ladders);
  Participate in executive reviews.
• Oversee the design and delivery of Standards training and best-practices to cross-functional teams.
• Provide operational expertise and guidance through training development, training delivery, and mentoring to members of the Global Clinical Data Standards team.
• Act as a leader in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development.
• Build cross-functional alignment with GDMS/ Global Clinical Trial Operations (GCTO)/ GCD [Global Clinical Development]) and partner functions on priorities, funding, and resourcing; represent the remit in leadership forums.
• Provide oversight and expertise within one or multiple TAs on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.
• Support direct reports who actively participate and represent data standards as a sitting member for assigned design teams.
• Serve as an escalation point for study-level design core teams, as needed.
• Provide prioritization and ensure appropriate resource allocation to future standards library development activities and/or new and/or modified processes.
• Provide expertise and guidance to frame options to facilitate decision making.
• Contribute to the development of the strategic direction for new processes and tools supporting clinical data standards and information management capabilities.
• Draft implementation plans.
• Work with leadership and colleagues to define and implement Standards metrics (e.g., conformance, reuse, change rationale); support tracking, root-cause identification, and synthesis of findings.
• Work with fellow Global Clinical Data Standards leadership on prioritization and delivery of the Book of Business, set the strategic vision for the Global Clinical Data Standards organization, new functional programs/projects, and governance demands.
• Actively participate in cross-functional (e.g., GDMS/GCTO/GCD [Global Clinical Development]) strategic projects.
• Act as an escalation point on governance decisions, including changes to existing library forms and new content.
• Accountable for oversight of the integrity of data collection standards libraries and associated components.
• Serve as a member of the GCDS (Global Clinical Data Standards) Leadership Team and proactively engage with stakeholders inside and outside of Global Clinical Data Standards and across global sites to drive efforts critical to the success of Global Clinical Data Standards and GDMS (Global Data Management and Standards) more broadly.
• Participate in assigned operational and study team forums ensuring clinical data standards align with industry standards, our Company standards and processes, and information management best practices.

• Set clear objectives aligned to organizational goals; assign work and set priorities.
• 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; manage sensitive employee-relations matters in partnership with HR.
• Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.
• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spend against priorities.
• Align teams around a clear direction; facilitate team/functional meetings.
• Provide concise, decision-ready updates and status reporting to leadership and partners.