Responsibilities:
- Provide input into the design of data flow across EDC and non-EDC data sources across the vendor network.
- Manage data management service providers to ensure deliverable quality and timelines.
- Develop and contribute to processes enabling near-real-time data access for clinical trials.
- Implement CDISC compliance to ensure clinical database data quality.
- Review and critically assess data query resolution metrics and suggest process improvements.
- Review study protocols to ensure data collection and CRF design meet study objectives.
- Manage and oversee SAE and external vendor reconciliation between clinical and applicable databases.
- Review clinical data for completeness, accuracy, and consistency per the investigational plan.
- Provide subject matter expertise to project team members through all phases of the project life cycle.
- Provide accurate, timely clinical data to internal and external customers upon request.
- Manage development, testing, and maintenance of data management systems.
- Support development and periodic review of Data Management SOPs, WIs, and templates.
- Provide subject matter expertise before, during, and after internal/external audits and inspections.
- Maintain compliance with company and study-specific learning requirements.
Preferred Skills/Qualifications/Proficiencies:
- Relational database experience; SAS; clinical data management systems.
- CDISC/SDTM knowledge (hands-on preferred).
- Hands-on experience with mainstream EDC systems (e.g., Rave, Medrio).
- Familiarity with data visualization tools (e.g., Tableau, RShiny) is a plus.
- Data management regulatory guideline knowledge: ICH, GCDMP, 21 CFR Part 11.
- Demonstrated management abilities for project/staff management of data management deliverables.
Preferred Education/Experience:
- Bachelorβs or higher in science, math, or computer science.
- 5+ yearsβ clinical trial industry data management experience.
- IT-related experience.
- Oncology or rare disease clinical trial experience; CDISC therapeutic area standards.
- Experience managing data flow and curating biomarker data.
- Experience managing Data Management CROs and vendors.