- Lead day-to-day data management activities for assigned clinical trials (Phase 2 and Phase 1b)
- Oversee CRO and vendor data management deliverables to ensure timelines, quality, and compliance
- Review and contribute to key study documents, including Data Management Plans (DMPs), Case Report Forms (CRFs) / eCRFs, edit check specifications, and data transfer specifications
- Manage database build, UAT, and database lock activities
- Ensure data integrity, consistency, and completeness through ongoing data review and cleaning
- Monitor query generation and resolution timelines
- Perform data review, listings review, and support medical data review activities
- Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets
- Ensure compliance with GCP, regulatory requirements, and company SOPs
- Support inspection readiness and participate in audits/inspections as needed
GCP