Responsibilities:
- Provide oversight and guidance to define and maintain standard data collection (EDC and non-EDC) definitions aligned to CDISC standards and Health Authority guidance.
- Accountable for timely delivery of standards/governance deliverables across sub-units (resource forecasting, process optimization, operations reviews, innovation).
- Provide strategic direction for Standards training/best practices and mentoring; oversee training materials and delivery.
- Lead industry engagement; build/sustain senior stakeholder networks; broker decisions and remove blockers.
- Provide expertise on data collection/data transformation design and data modeling; ensure consistency with standards.
- Participate in governance initiatives/reviews (e.g., TAST, SLIC), lead cross-functional projects, and serve as escalation point for study-level design and governance decisions.
- Prioritize and oversee standards metrics; communicate metrics to Executive Leadership.
People Management:
- Set objectives; coach/check-in annually; develop career plans; lead recruiting/hiring; manage budgets; coordinate global/on-offshore resources; provide status updates.
Technical/Preferred Skills:
- Clinical information standards governance and implementation; CDISC (CDASH/SDTM/ADaM), HL7; submission deliverables (SDRG/ADRG/Define.xml); clinical development trial/data management/regulatory DM.
- Preferred: ACRP-CP; eCRF/DB validation/UAT/extraction/SDTM transformation; PMP; FAIR/ALCOA.
Qualifications:
- Bachelorβs + 15 years Clinical Data Management (or related), incl. 3 years standards/metadata and 10 years people management; or Master/Doctorate + 13 years.
Required Skills: Client-focused clinical data management, clinical study management, conflict resolution, data processing/validation, GCP, protocol review, strategic planning.
Benefits/Apply:
- Salary range: $173,200β$272,600; eligible for annual bonus/LTI (if applicable). Benefits include medical/dental/vision, 401(k), paid holidays/vacation, sick/compassionate days.
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub).