Related skills
cdisc sdtm lims rave cdash📋 Description
- Serve as Arvinas SME and POC for external data management across studies and data exchanges with the clinical database.
- Oversee biosample movements between central lab and analyzing lab; vendor oversight of DM CROs.
- Develop standardized data flows and SDTM-compliant data transfers to the clinical database.
- Provide ad hoc support for EDC acceptance testing and SDTM data structure reviews.
- Oversee DM CRO/Vendors; review DM documentation including Data Interchange and Data Quality Oversight Plans.
- Support clinical study data review using JReview and maintain the Data Listings Repository.
🎯 Requirements
- 10+ years in clinical data science, data management, and biometrics
- Deep expertise in external data management and data interchange
- Strong understanding of central labs and LIMS
- Extensive experience with EDC systems (Rave) and sponsor testing
- Proficient in J-Review and data visualization
- CDASH, CDISC, and SDTM standards expertise
🎁 Benefits
- Competitive base salary and incentive program
- Comprehensive medical, vision, and dental coverage
- Group and supplemental life insurance
- Health and wellness programs and resources
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