Responsibilities
- Oversee and guide definition and maintenance of standard data collection (EDC and non-EDC) aligned to industry standards (e.g., CDISC) and Health Authority guidance.
- Coordinate delivery of standards/governance deliverables across GCDS sub-units (resource forecasting, process optimization, operations reviews, innovation).
- Provide strategic direction for standards training/best practices; develop training materials and mentor the Global Clinical Data Standards team.
- Lead/participate in initiatives; support audits/inspections.
- Act as escalation point for governance decisions and study-level design; communicate implementation plans and standards metrics to stakeholders and Executive Leadership.
- Build senior stakeholder networks; influence industry forums and strategic clinical data standards development.
People Management
- Set objectives, assign priorities; conduct check-ins/reviews, coaching, recognition; develop career plans.
- Lead recruiting/hiring; manage employee relations with HR; manage budgets; balance workloads and oversee resource models.
Technical Skills
- Extensive experience governing clinical information standards and implementing clinical data standards.
- Deep knowledge of CDISC/Controlled Terminologies (CDASH, SDTM, ADaM, HL7) and submission deliverables (e.g., SDRG/ADRG/Define.xml).
- Strong clinical development and regulatory DM/reporting understanding; program-level requirements impact.
Qualifications
- Bachelorβs + 15 years Clinical Data Management (or related); includes 3 years standards/metadata and 10 years people management.
OR Advanced degree + 13 years (includes 3 years standards/metadata and 10 years people management).