Responsibilities:
- Act as CDM lead with oversight of Clinical Data Management (CDM) activities at the project level (product or complex studies).
- Lead CRF/eCRF design; review study protocols and plan/implement CDM portions of clinical studies.
- Oversee vendors for data review, data transfers, and reporting; track study progress using routine and non-routine reports to meet timelines and quality expectations.
- Provide guidance/training to CROs, vendors, investigators, and study coordinators on CDM requirements; manage CDM queries/issues.
- Ensure completeness, accuracy, and consistency of clinical data and data structure; ensure compliance with CDM processes and regulatory requirements.
- Lead CDM process design/implementation with vendors (data entry, quality checking, transfer, reporting, backup/recovery).
- Support regulatory submissions; assist with responses to audits/inspections; may lead special projects.
Preferred Qualifications:
- Relevant CDM or data analytics/data management experience, including leading small projects/teams.
- Demonstrated proficiency in CDM deliverables and timelines/metrics.
- Advanced knowledge of FDA/EMA regulations; NDA and web-based EDC/CDM systems.
- Strong project/risk management, communication/organization, facilitation, and ability to coach.
- When needed, ability to travel.
Benefits (if applicable as stated):
- Discretionary annual bonus, stock-based long-term incentives (eligibility varies), paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees/contractors: Apply via the Internal Career Opportunities portal in Workday.