Clinical Data Management (CDM) supports drug discovery, development and marketed products by ensuring accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF/eCRF design, editing specifications and query resolution. CDM also manages data transfers from vendors (e.g., central labs).
You will act as CDM lead with oversight of CDM activities at the project level (product or multiple complex studies within an indication). Lead CRF/eCRF design, review study protocols, plan and implement CDM portions of clinical studies, oversee vendors for data review/transfer/reporting quality, track progress with routine/non-routine reports, provide guidance/training to CROs, vendors, investigators and study coordinators, and support regulatory submissions and audit/inspection responses. May lead special projects across CDM teams.
Key Responsibilities:
- Lead one or more studies/projects of increasing complexity; participate/lead cross-functional working groups.
- Review protocols; support site/field staff in timely routine data collection.
- Identify, track, and resolve CDM queries/issues.
- Point of contact for data management issues.
- Ensure completeness, accuracy and consistency of clinical data and structure.
- Ensure compliance with CDM business processes and regulatory requirements.
- Lead CDM process design/implementation with vendors (entry, QC, transfer, reporting, backup/recovery).
- Educate study teams/vendors on CDM processes/deliverables.
- Lead CRF/eCRF design and use reports to ensure timelines/quality.
- Address regulatory submission needs; support responses to audits/inspections.
- Provide technical/business expertise for new technologies/vendors.
- Lead/participate in continuous improvements, SOPs and guidance.
- Lead/participate in organizing/analyzing interim clinical data.
- Communicate effectively; train/mentor colleagues.
Preferred Qualifications:
- CDM or data analytics/data management experience (including leading small projects/teams).
- Proficiency leading CDM deliverables; understanding timelines/metrics.
- Understanding of FDA/EMA regulations and EDC/CDM systems; risk/project management.
- Strong facilitation/presentation, delegation, coaching, communication/organization; ability to travel when needed.
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.