Responsibilities:
- Select and maintain preferred vendor network for data management activities.
- Review/propose/obtain bids for tools enabling real-time data visualization, interrogation, and reporting.
- Manage strategic input into data flow design across EDC and non-EDC data sources.
- Manage data management service providers to ensure quality deliverables and timelines.
- Develop and contribute to processes enabling near-real-time data access for clinical trials.
- Ensure data quality through CDISC compliance.
- Review and assess data query resolution metrics; suggest process improvements.
- Review study protocols to ensure data collection and CRF design meet study objectives.
- Manage/oversee SAE reconciliation between clinical and pharmacovigilance databases.
- Review clinical data for completeness, accuracy, and consistency.
- Provide subject matter expertise across project lifecycle phases.
- Provide accurate/timely clinical data to internal/external customers.
- Develop, test, and maintain data management systems.
- Develop and periodically review Data Management SOPs, WIs, and templates.
- Provide subject matter expertise for internal/external audits and inspections.
- Maintain compliance with company and study-specific learning requirements.
Preferred Qualifications/Skills:
- Masterβs in health care or life sciences (preferred).
- Relational databases; SQL, SAS; clinical data management systems.
- MedDRA, WHODrug, and related thesaurus classification systems.
- CDISC/SDTM knowledge (hands-on preferred).
- EDC systems experience (e.g., Rave, Medrio, Inform).
- Data visualization tools (Spotfire, Tableau, RShiny).
- Regulatory guidelines: ICH, GCDMP, 21 CFR Part 11.
Preferred Education/Experience:
- BS or higher in science, math, or computer science.
- 10+ years in clinical trial industry; 10+ years in clinical data management.
- 3+ years medical coding (MedDRA/WHODrug) within Medidata Rave Coder.
- Strong MedDRA/WHODrug dictionary knowledge.
- Experience managing Data Management CROs; direct report oversight.
- Minimum 3 years in Medidata Rave Coder; endocrinology trials/CDISC therapeutic area standards (plus).