Senior Manager, Clinical Data Standards
Immunocore
1 month ago
Remote friendly (Gaithersburg, MD)
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 support efficient mapping to SDTM.
- Govern Global Library versioning and implementation across the portfolio for cross-study consistency.
- Define and maintain standards for non-EDC data transfer specifications (DTS) to standardize vendor data (Labs, PK, eCOA, Imaging) for ingestion.
- Collaborate with Clinical Operations and Vendor Management to ensure third-party providers follow data standards from study startup.
- Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA) to harmonize vendor data intake.
- Liaison with Clinical Programming and Biostatistics to ensure collection standards support downstream reporting strategy (SDTM/ADaM).
- Participate in standards governance forums regarding impacts to site burden and EDC build.
- Ensure “Traceability by Design” is incorporated into CRFs from raw capture to analysis-ready datasets.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva) for adherence to global collection standards.
- Lead standards kick-offs for new programs; ensure CROs and internal teams understand requirements and integration points.
- Conduct standards compliance audits on study-level builds to identify and mitigate deviations early.
- Drive Metadata Repository (MDR) implementation focused on front-end mapping (CRF to SDTM).
- Author and maintain SOPs and Work Instructions for data collection standards, cleaning standards, and external data integration.
- Ensure Trial Master File (TMF) is inspection-ready for data collection documentation (specifications and validation records).
Essential Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years in Clinical Data Management, including 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 (e.g., biomarker, eCOA, central lab).
- Expert knowledge of CDASH and working knowledge of SDTM.
- Familiarity with regulatory guidelines (ICH-GCP, FDA, EMA).
- Experience in small-to-mid-size biotech with ability to pivot between strategy and execution.
- Excellent attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Non-Essential Qualifications:
- Experience with Metadata Repository (MDR) implementation.
- Knowledge of Digital Health Technology (DHT) data standards (e.g., wearables, sensors).
- Proficiency with SAS, SQL, or other data analysis tools (SQL/SAS for data profiling and quality oversight).
- Experience supporting global clinical trials and working with CROs/vendors.
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 support efficient mapping to SDTM.
- Govern Global Library versioning and implementation across the portfolio for cross-study consistency.
- Define and maintain standards for non-EDC data transfer specifications (DTS) to standardize vendor data (Labs, PK, eCOA, Imaging) for ingestion.
- Collaborate with Clinical Operations and Vendor Management to ensure third-party providers follow data standards from study startup.
- Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA) to harmonize vendor data intake.
- Liaison with Clinical Programming and Biostatistics to ensure collection standards support downstream reporting strategy (SDTM/ADaM).
- Participate in standards governance forums regarding impacts to site burden and EDC build.
- Ensure “Traceability by Design” is incorporated into CRFs from raw capture to analysis-ready datasets.
- Provide oversight of EDC database builds (e.g., Medidata Rave, Veeva) for adherence to global collection standards.
- Lead standards kick-offs for new programs; ensure CROs and internal teams understand requirements and integration points.
- Conduct standards compliance audits on study-level builds to identify and mitigate deviations early.
- Drive Metadata Repository (MDR) implementation focused on front-end mapping (CRF to SDTM).
- Author and maintain SOPs and Work Instructions for data collection standards, cleaning standards, and external data integration.
- Ensure Trial Master File (TMF) is inspection-ready for data collection documentation (specifications and validation records).
Essential Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- 8+ years in Clinical Data Management, including 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 (e.g., biomarker, eCOA, central lab).
- Expert knowledge of CDASH and working knowledge of SDTM.
- Familiarity with regulatory guidelines (ICH-GCP, FDA, EMA).
- Experience in small-to-mid-size biotech with ability to pivot between strategy and execution.
- Excellent attention to detail and analytical skills.
- Master’s degree or certification (e.g., CCDM, SAS Base Programmer).
Non-Essential Qualifications:
- Experience with Metadata Repository (MDR) implementation.
- Knowledge of Digital Health Technology (DHT) data standards (e.g., wearables, sensors).
- Proficiency with SAS, SQL, or other data analysis tools (SQL/SAS for data profiling and quality oversight).
- Experience supporting global clinical trials and working with CROs/vendors.
US Salary Range: $121,500-$202,500