Director, Clinical Data Management, Global Data Management and Standards

About the role

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.

Responsibilities

• 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;
• 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;
• 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;
• 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 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;
• 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.

Qualifications

• Bachelor’s Degree and minimum of 10 year's experience in Clinical Data Management (or related discipline), including: 3 years needs to be in clinical data standards development or metadata management;
• Minimum of 3 years people management experience (direct or matrix);
• Demonstrated deep subject matter expertise OR Advanced Degree (Masters or Doctorate) and minimum of 8 year's experience in Clinical Data Management (or related discipline), including: 3 years needs to be in clinical data standards development or metadata management;
• Minimum of 3 years people management experience;
• Demonstrated deep subject matter expertise clinicaltrialjobs EligibleforERP #GDMS Required Skills Clinical Data Management, Clinical Development, Clinical Trials, Collaborative Communications, Data Validation, eCRF, Electronic Data Capture (EDC), Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Metadata Management, People Management, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM), Team Leadership;
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