Senior Manager, Clinical Data Standards
Immunocore
9 hours ago
Remote friendly (Gaithersburg, MD)
United States
Clinical Research and Development
Key Responsibilities:
- Lead standardization of clinical data intake across EDC and non-EDC sources (Central Labs, Biomarkers, eCOA, Imaging) at point of entry.
- Own the “Collection-to-SDTM” pathway, aligning collection structures with SDTM/ADaM reporting strategy.
- Develop, maintain, and govern a Global Library (standard CRFs, edit check specifications, integration plans) and manage versioning for cross-study consistency.
- Ensure standards align with CDASH and optimize mapping to SDTM.
- Define and maintain non-EDC data transfer specifications (DTS) and partner with Clinical Ops/Vendor Management to ensure vendor adherence.
- Create standardized DMP/DTA templates; act as liaison to Clinical Programming and Biostatistics.
- Incorporate “Traceability by Design” into CRFs; provide oversight of EDC builds (Medidata Rave, Veeva).
- Lead standards kick-offs and perform compliance audits; drive MDR capabilities (CRF to SDTM mapping).
- Author SOPs/Work Instructions and ensure TMF inspection readiness for data collection documentation.
Essential Qualifications:
- Bachelor’s in Life Sciences/Computer Science or related field.
- 8+ years Clinical Data Management; 5+ years in Data Standards and EDC database design.
- Advanced Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC experience.
- Proven experience managing complex external data integrations (biomarkers, eCOA, central lab).
- Expert CDASH knowledge and strong SDTM knowledge.
- Familiarity with ICH-GCP, FDA, EMA.
- Ability to switch between strategy and execution; strong analytical/detail orientation.
- Master’s or certification (e.g., CCDM, SAS Base Programmer).
Non-Essential Qualifications:
- MDR implementation; DHT standards; SAS/SQL data profiling.
US Salary Range: $121,500–$202,500
- Lead standardization of clinical data intake across EDC and non-EDC sources (Central Labs, Biomarkers, eCOA, Imaging) at point of entry.
- Own the “Collection-to-SDTM” pathway, aligning collection structures with SDTM/ADaM reporting strategy.
- Develop, maintain, and govern a Global Library (standard CRFs, edit check specifications, integration plans) and manage versioning for cross-study consistency.
- Ensure standards align with CDASH and optimize mapping to SDTM.
- Define and maintain non-EDC data transfer specifications (DTS) and partner with Clinical Ops/Vendor Management to ensure vendor adherence.
- Create standardized DMP/DTA templates; act as liaison to Clinical Programming and Biostatistics.
- Incorporate “Traceability by Design” into CRFs; provide oversight of EDC builds (Medidata Rave, Veeva).
- Lead standards kick-offs and perform compliance audits; drive MDR capabilities (CRF to SDTM mapping).
- Author SOPs/Work Instructions and ensure TMF inspection readiness for data collection documentation.
Essential Qualifications:
- Bachelor’s in Life Sciences/Computer Science or related field.
- 8+ years Clinical Data Management; 5+ years in Data Standards and EDC database design.
- Advanced Medidata Rave (Architect/Global Library) or Veeva CDB/Vault EDC experience.
- Proven experience managing complex external data integrations (biomarkers, eCOA, central lab).
- Expert CDASH knowledge and strong SDTM knowledge.
- Familiarity with ICH-GCP, FDA, EMA.
- Ability to switch between strategy and execution; strong analytical/detail orientation.
- Master’s or certification (e.g., CCDM, SAS Base Programmer).
Non-Essential Qualifications:
- MDR implementation; DHT standards; SAS/SQL data profiling.
US Salary Range: $121,500–$202,500