What are the responsibilities and job description for the Clinical Data Management SME position at Vedan Technologies?
Required Qualifications
- 10 years of experience in Clinical Data Management within pharma, biotech, or CRO environments.
- Strong working knowledge of CDISC, SDTM, and ADaM standards.
- Experience with:
- Clinical Data Management Plans
- Data Quality Plans
- Data Transfer Plans
- eCRF specifications
- SDTM/ADaM mapping specifications
- Edit checks and validation rules
- Clinical data review and reconciliation
- Ability to interpret study protocols, eCRFs, CRF annotations, reporting plans, and analysis plans.
- Experience managing or coordinating with CROs and third-party data vendors.
- Strong understanding of clinical trial data lifecycle from data collection through analysis and submission readiness.
- Ability to convert clinical requirements into clear technical specifications.
- Strong communication and stakeholder management skills.