- Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
- Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.
- Lead hands-on CRF design and review, ensuring alignment with protocol objectives-, statistical analysis plans, and regulatory expectations.
- Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.
- Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
- Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready- datasets.
- Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based-monitoring approaches for clinical data.
- Lead hands-on-oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.
- Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
- Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.
GCP