Role- Senior Clinical Data Management SME
Location - Onsite, Alameda, CA (Near Oakland Airport)
We are seeking a
Senior Clinical Data Management SME to provide clinical data leadership across active studies. This role will own clinical data standards, study-level data management planning, data quality planning, SDTM/ADaM mapping oversight, CRO/vendor data onboarding, and translation of clinical study requirements into data pipeline specifications.
The role requires deep experience in
clinical data management, CDISC standards, SDTM/ADaM, eCRF design, study protocols, data quality, vendor governance, and clinical data delivery.
Key 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.
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.
Preferred Qualifications
- Experience with regulatory submission data packages.
- Experience with EDC systems, clinical data repositories, clinical data hubs, or clinical data platforms.
- Familiarity with metadata-driven pipelines, automation, or AI-assisted data mapping and rule generation.
- Experience supporting oncology or specialty pharma studies.
- Experience working with distributed onsite/offshore delivery teams.
- Knowledge of data governance, lineage, auditability, and quality controls in clinical data environments.
Key Skills
Clinical Data Management, CDISC, SDTM, ADaM, eCRF, Study Protocols, Data Quality, Data Transfer Plans, CRO/Vendor Governance, Data Mapping, Clinical Data Standards, Edit Checks, Data Reconciliation, Regulatory Submission Readiness, Clinical Operations, Biostatistics, Data Engineering Collaboration.
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