Senior Manager, Clinical Data Standards

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).

• 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).

• 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