Senior Manager, Clinical Data Standards

Key Responsibilities:
- Lead the development, maintenance, and governance of the Global Library for data collection (standard CRFs, edit check specifications, and data integration plans).
- Ensure all collection standards are aligned with CDASH and optimized for efficient mapping to SDTM.
- Govern Global Library versioning and implementation across the portfolio to ensure cross-study consistency.
- Define and maintain standards for non-EDC data transfer specifications (DTS) for external vendor data (Labs, PK, eCOA, Imaging).
- Collaborate with Clinical Operations and Vendor Management to ensure third-party providers adhere to data standards from study startup.
- Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA) to harmonize vendor data intake.
- Serve as liaison to Clinical Programming and Biostatistics to ensure collection standards support downstream reporting (SDTM/ADaM).
- Participate in standards governance forums; provide collection perspective on reporting requirements, site burden, and EDC build.
- Incorporate “Traceability by Design” into CRFs for traceability 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 (CROs and internal teams) on collection requirements and integration points.
- Perform standards compliance audits on study-level builds to identify and mitigate deviations early.
- Drive MDR capabilities 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 with 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; at least 5 years focused on 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., high-volume biomarker data, eCOA, central lab data).
- Expert knowledge of CDASH and working knowledge of SDTM to ensure collection supports reporting.
- Familiarity with ICH-GCP, FDA, and EMA regulatory guidelines.
- Experience in a small-to-mid-size biotech; ability to pivot between strategy and study 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 profiling and quality oversight).
- Experience supporting global clinical trials and working with CROs/vendors.

Compensation:
- US Salary Range: $121,500-$202,500