Clinical Data Standards Lead — SDTM/ADaM

BioSpace; Radnor (Delaware County); Hybrid; USD 122,000 - 203,000; Full time

Job summary

Immunocore is seeking a Senior Manager, Clinical Data Standards to lead the standardization of clinical data intake across EDC and non-EDC sources. You will own the Collection-to-SDTM pathway, aligning data structures with SDTM/ADaM and driving governance of the Global Library.

You will collaborate with Clinical Operations, Biostatistics, and CROs to ensure cross-study consistency and high-quality data integration, enabling robust downstream reporting and regulatory readiness.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• 8+ years in Clinical Data Management with 5+ years in Data Standards and EDC design.
• Expert CDASH knowledge and SDTM familiarity for reporting.
• Regulatory guidelines knowledge (ICH-GCP, FDA, EMA).
• Experience with external data integrations and CRO/vendor coordination.
• Master’s or CCDM/SAS certification is a plus.

Responsibilities

• Lead development, maintenance, and governance of the Global Library for data collection and edit checks.
• Ensure collection standards align with CDASH and SDTM for downstream reporting.
• Govern library versioning for cross-study consistency across portfolios.
• Define non-EDC data transfer specifications (DTS) for external data ingestion.
• Collaborate with Clinical Operations and Vendor Management to ensure standards adherence.
• Develop standardized templates for Data Management Plans and Data Transfer Agreements.
• Act as liaison to Clinical Programming and Biostatistics to support SDTM/ADaM.
• Participate in governance forums to balance site burden with EDC build needs.
• Ensure Traceability by Design from CRF to analysis-ready datasets.
• Provide oversight of EDC builds (Medidata Rave, Veeva) for standards compliance.
• Lead standards kick-offs for new programs with CROs and internal teams.
• Perform standards compliance audits early in the study lifecycle.
• Drive Metadata Repository capabilities focusing on front-end mapping.
• Author SOPs and work instructions for data collection and integration.
• Ensure TMF readiness for data collection documentation and validation.

Skills

CDASH standards

SDTM mapping

Data standards governance

EDC data collection

Data integration planning

DTS specifications

Vendor data management

Traceability by design

Template development for DMP/DTA

CRF to SDTM mapping

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree or CCDM/SAS certification

Tools

Medidata Rave

Veeva Vault/EDC

SAS

SQL

Job description

Immunocore is seeking a Senior Manager, Clinical Data Standards to lead the standardization of clinical data intake across EDC and non-EDC sources. You will own the Collection-to-SDTM pathway, aligning data structures with SDTM/ADaM and driving governance of the Global Library.

You will collaborate with Clinical Operations, Biostatistics, and CROs to ensure cross-study consistency and high-quality data integration, enabling robust downstream reporting and regulatory readiness.