Senior Manager, Clinical Data Standards
Immunocore
June 28, 2026
Remote friendly (Radnor, PA)
United States
Clinical Research and Development
Key Responsibilities:
- Lead development, maintenance, and governance of the Global Library for data collection (standard CRFs, edit check specifications, data integration plans).
- Ensure collection standards align with CDASH and optimize mapping to SDTM.
- Govern Global Library versioning and implementation for cross-study consistency.
- Define and maintain non-EDC data transfer specifications (DTS) for vendor data (Labs, PK, eCOA, Imaging).
- Collaborate with Clinical Operations and Vendor Management to ensure third-party adherence from study startup.
- Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA).
- Partner with Clinical Programming and Biostatistics to support downstream SDTM/ADaM reporting strategy.
- Participate in standards governance forums; address impact on site burden and EDC build.
- Incorporate “Traceability by Design” into CRFs.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva) to ensure standards adherence.
- Lead standards kick-offs and perform standards compliance audits on study-level builds.
- Drive Metadata Repository (MDR) capabilities for front-end mapping (CRF to SDTM).
- Author/maintain SOPs and Work Instructions for data collection standards, cleaning standards, and external integration.
- Ensure TMF is inspection-ready for data collection documentation.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years in Clinical Data Management; at least 5 years in Data Standards and EDC Database Design.
- Advanced experience with Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC.
- Proven experience managing complex external data integrations (biomarkers, eCOA, central labs).
- Expert knowledge of CDASH; strong working knowledge of SDTM.
- Familiarity with ICH-GCP, FDA, and EMA.
- Experience in small-to-mid-size biotech; strong attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Preferred Qualifications:
- Experience with MDR implementation.
- Knowledge of Digital Health Technology data standards.
- Proficiency with SAS/SQL (or similar) for data profiling/quality oversight.
- Experience supporting global trials and working with CROs/vendors.
Compensation (US Salary Range): $121,500-$202,500.
- Lead development, maintenance, and governance of the Global Library for data collection (standard CRFs, edit check specifications, data integration plans).
- Ensure collection standards align with CDASH and optimize mapping to SDTM.
- Govern Global Library versioning and implementation for cross-study consistency.
- Define and maintain non-EDC data transfer specifications (DTS) for vendor data (Labs, PK, eCOA, Imaging).
- Collaborate with Clinical Operations and Vendor Management to ensure third-party adherence from study startup.
- Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA).
- Partner with Clinical Programming and Biostatistics to support downstream SDTM/ADaM reporting strategy.
- Participate in standards governance forums; address impact on site burden and EDC build.
- Incorporate “Traceability by Design” into CRFs.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva) to ensure standards adherence.
- Lead standards kick-offs and perform standards compliance audits on study-level builds.
- Drive Metadata Repository (MDR) capabilities for front-end mapping (CRF to SDTM).
- Author/maintain SOPs and Work Instructions for data collection standards, cleaning standards, and external integration.
- Ensure TMF is inspection-ready for data collection documentation.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years in Clinical Data Management; at least 5 years in Data Standards and EDC Database Design.
- Advanced experience with Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC.
- Proven experience managing complex external data integrations (biomarkers, eCOA, central labs).
- Expert knowledge of CDASH; strong working knowledge of SDTM.
- Familiarity with ICH-GCP, FDA, and EMA.
- Experience in small-to-mid-size biotech; strong attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Preferred Qualifications:
- Experience with MDR implementation.
- Knowledge of Digital Health Technology data standards.
- Proficiency with SAS/SQL (or similar) for data profiling/quality oversight.
- Experience supporting global trials and working with CROs/vendors.
Compensation (US Salary Range): $121,500-$202,500.