Senior Manager, Clinical Data Standards
Immunocore
August 11, 2026
Remote friendly (Radnor, PA)
United States
Clinical Research and Development
Key Responsibilities:
- Lead the 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 are optimized for efficient mapping to SDTM.
- Govern Global Library versioning and implementation across the portfolio for cross-study consistency.
- Define/maintain non-EDC data transfer specifications (DTS) for standardized vendor ingestion (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).
- Liaison to Clinical Programming and Biostatistics to ensure collection supports the downstream reporting strategy (SDTM/ADaM).
- Incorporate “Traceability by Design” into CRFs.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva).
- Lead standards kick-offs; perform standards compliance audits on study-level builds.
- Drive Metadata Repository (MDR) implementation (CRF to SDTM mapping).
- Author/maintain SOPs and Work Instructions for data collection standards and external integration.
- Ensure Trial Master File (TMF) is inspection-ready for data collection documentation.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years Clinical Data Management; 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.
- Expert knowledge of CDASH and strong working knowledge of SDTM.
- Familiarity with ICH-GCP, FDA, EMA.
- Experience in small-to-mid-size biotech; ability to pivot strategy to execution.
- Excellent attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Preferred Qualifications:
- MDR implementation experience; DHT data standards exposure.
- Proficiency in SAS/SQL or other data analysis tools (profiling/quality oversight).
- Experience with global trials and working with CROs/vendors.
US Salary Range: $121,500–$202,500
- Lead the 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 are optimized for efficient mapping to SDTM.
- Govern Global Library versioning and implementation across the portfolio for cross-study consistency.
- Define/maintain non-EDC data transfer specifications (DTS) for standardized vendor ingestion (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).
- Liaison to Clinical Programming and Biostatistics to ensure collection supports the downstream reporting strategy (SDTM/ADaM).
- Incorporate “Traceability by Design” into CRFs.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva).
- Lead standards kick-offs; perform standards compliance audits on study-level builds.
- Drive Metadata Repository (MDR) implementation (CRF to SDTM mapping).
- Author/maintain SOPs and Work Instructions for data collection standards and external integration.
- Ensure Trial Master File (TMF) is inspection-ready for data collection documentation.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years Clinical Data Management; 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.
- Expert knowledge of CDASH and strong working knowledge of SDTM.
- Familiarity with ICH-GCP, FDA, EMA.
- Experience in small-to-mid-size biotech; ability to pivot strategy to execution.
- Excellent attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Preferred Qualifications:
- MDR implementation experience; DHT data standards exposure.
- Proficiency in SAS/SQL or other data analysis tools (profiling/quality oversight).
- Experience with global trials and working with CROs/vendors.
US Salary Range: $121,500–$202,500