Hi,
Greetings from Uniqsoft INC!!!
We have "Senior Clinical Data Management SME" Open positions at "Alameda, CA (Onsite)" – Long term Contract position.
Job Title: Senior Clinical Data Management SME
Location: Alameda, CA (Onsite)
Position type: Long term Contract
Responsibilities:
- Serve as the primary Clinical Data Management SME across active clinical studies.
- Own and maintain CDISC standards, Clinical Data Management Plans, and Data Quality Plans.
- Own SDTM/ADaM mapping authority across studies and validate domain conformance.
- Review and approve SDTM/ADaM mappings, data quality rules, and study artifacts before release to production.
- Govern CRO and vendor data onboarding, including data transfer plans, SLAs, acceptance criteria, in-stream data flows, and exception handling.
- Translate study protocols, eCRFs, and reporting/analysis plans into pipeline requirements for data engineering teams.
- Partner with Clinical Operations, Biostatistics, Data Management, CROs, data engineers, and data managers.
- Ensure study data is complete, accurate, traceable, standardized, and ready for downstream analysis.
- Provide SME guidance to offshore engineers and data managers on clinical data standards, mappings, and study-specific requirements.
- Support issue resolution related to clinical data quality, mapping gaps, transformation logic, and vendor data defects.
Skills Matrix:
Total work experience in IT Industry:
Total work experience in USA:
Senior Clinical Data Management SME: Years
SDTM/ADaM mapping authority: Years
CDISC standards: Years
Thanks and Have A Wonderful Day,
Srikanth
(Technical Recruiter)
Uniqsoft INC, |4025 Tiber Falls Dr, Ellicott City, MD 21043 |
Direct: 443-636-2517
FAX: 443-288-4584| Email: srikanth@uniqsoftinc.com | www.uniqsoftinc.com
Hangout: srikanthrecruiter1103@gmail.com
Linkedin: linkedin.com/in/srikanthkasha
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