Senior Clinical Data Management SME

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.