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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