Clinical Data Management (CDM) supports drug discovery, development, and marketed products by ensuring accurate and timely acquisition, analysis, and reporting of clinical data through CRF/eCRF design, editing specifications, and query resolution, including vendor data transfers.
You will act as CDM lead with oversight for project-level CDM activities (e.g., products or complex studies), lead CRF/eCRF design, review study protocols, plan and implement CDM portions of clinical studies, oversee vendors for data review/transfer/reporting, track progress/timelines/quality, guide and train CROs/vendors/investigators/study coordinators on CDM requirements, and support regulatory submissions and CDM responses for audits/inspections; may lead cross-team special projects.
Key Responsibilities:
- Lead one or more studies/projects; participate/lead cross-functional working groups.
- Review protocols; support timely routine data collection.
- Identify, track, and resolve CDM queries/issues.
- Point of contact for study management and Clinical Development on data management issues.
- Ensure data completeness/accuracy/consistency and CDM system process compliance.
- Lead vendor CDM process design/implementation (entry, QC, transfer, reporting, backup/recovery).
- Prepare CRF/eCRF design; use reports to ensure timelines and quality.
- Provide technical/process expertise on emerging technologies/vendors.
- Develop/implement CDM continuous improvements, SOPs, and guidance.
- Lead/participate in interim clinical data gathering/analysis.
- Communicate scientifically; train/mentor less experienced colleagues.