Clinical Data Management SME with Data Architectecture or Data Engineering Experience

Data Architect or Senior Data Engineer with experience in Clinical SDTM Data Management***

The SME should have strong experience working in clinical IT environments with a strong business-facing orientation, closely partnering with stakeholders across Biostatistics, Statistical Programming, Clinical Operations, and Clinical Data Management.

This role requires deep hands-on expertise in clinical data standards and regulatory submission datasets, with frequent collaboration with Biostatistics teams to ensure high-quality downstream analysis-ready data.

Key Responsibilities & Collaboration Areas

Work closely with Biostatistics teams to support study design, analysis readiness, and submission data strategy

Partner with Statistical Programmers to ensure correct implementation of analysis datasets

Collaborate with Clinical Data Managers (CDM) to ensure source data aligns with downstream SDTM requirements

Interface with Clinical Operations (Clin Ops) to ensure operational data capture supports analysis needs

Act as a bridge between IT systems/data architecture and clinical study execution teams

Core Technical Expertise Required

Strong expertise in CDISC standards, especially:

CDISC Standards

Deep knowledge of SDTM (Study Data Tabulation Model) including:

Domain structures and mapping from raw clinical data

Controlled terminology and implementation guidelines

Submission-ready SDTM datasets

Strong understanding of ADaM (Analysis Data Model):

Dataset creation for statistical analysis

Traceability from SDTM ? ADaM ? TLFs (Tables, Listings, Figures)

Experience with SDTM domain mapping specifications and transformation logic

Familiarity with regulatory submission expectations (e.g., FDA/PMDA)

Ideal Profile

Proven experience working in clinical trial data environments

Hands-on exposure to SDTM and ADaM dataset creation or review

Strong ability to translate between:

Clinical/business requirements

Statistical analysis needs

Technical data structures

Comfortable engaging in deep technical discussions with biostatisticians

Ability to act as a translation layer between IT/data systems and scientific teams

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.

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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.

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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:

o Clinical Data Management Plans

o Data Quality Plans

o Data Transfer Plans

o eCRF specifications

o SDTM/ADaM mapping specifications

o Edit checks and validation rules

o 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.

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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.

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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.