Senior Manager, Clinical Data Standards

Location of role Gaithersburg, MD, Radnor, PA

Department Clinical Operations

The Senior Manager, Clinical Data Standards is the strategic lead for the standardization of all clinical data intake streams. This role ensures that data collected via Electronic Data Capture (EDC) and non-EDC sources (e.g., Central Labs, Biomarkers, eCOA, Imaging) is standardized at the point of entry to ensure high quality, consistency, and seamless integration. You will own the "Collection-to-SDTM" pathway, ensuring that all data collection structures are built to align with and support the downstream reporting standards strategy (SDTM/ADaM) led by Clinical Programming and Biostatistics.

• Lead the development, maintenance, and governance of the Global Library for data collection, including standard CRFs, edit check specifications, and data integration plans.
• Ensure all collection standards are strictly aligned with CDASH and optimized for efficient mapping to SDTM.
• Govern the versioning and implementation of the Global Library across the portfolio to ensure cross-study consistency.
• Define and maintain standards for non-EDC data transfer specifications (DTS), ensuring that external vendor data (Labs, PK, eCOA, Imaging) is standardized for easy ingestion.
• Collaborate with Clinical Operations and Vendor Management to ensure third-party providers adhere to company data standards from study startup.
• Develop standardized templates for Data Management Plans (DMP) and Data Transfer Agreements (DTA) to harmonize data intake across all vendors.
• Act as the primary liaison to Clinical Programming and Biostatistics to ensure collection standards fully support downstream reporting strategy (SDTM/ADaM).
• Participate in standards governance forums to provide the collection perspective on how reporting requirements impact site burden and EDC build.
• Ensure "Traceability by Design" is incorporated into CRFs, enabling a clear path from raw data capture to analysis-ready datasets.
• Provide expert oversight of EDC database builds (e.g., Medidata Rave, Veeva) to ensure adherence to global collection standards.
• Lead standards kick-offs for new programs, ensuring CROs and internal teams understand collection requirements and integration points.
• Perform standards compliance audits on study-level builds to identify and mitigate deviations early in the study lifecycle.
• Drive implementation of Metadata Repository (MDR) capabilities focused on front-end mapping (CRF to SDTM).
• Author and maintain SOPs and Work Instructions related to data collection standards, cleaning standards, and external data integration.
• Ensure the Trial Master File (TMF) is inspection-ready for data collection documentation, including specifications and validation records.

• Bachelor’s degree in Life Sciences, Computer Science, or a related field.
• 8+ years in Clinical Data Management, with 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 track record of managing complex external data integrations (e.g., high-volume biomarker data, eCOA, or central lab data).
• Expert-level knowledge of CDASH and a strong working knowledge of SDTM (sufficient to ensure collection supports reporting).
• Familiarity with regulatory guidelines (ICH-GCP, FDA, EMA).
• Experience in a small-to-mid-size biotech where the ability to pivot between high-level strategy and study-level execution is required.
• 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 in SAS, SQL, or other data analysis tools. Familiarity with SQL or SAS for data profiling and quality oversight.
• Experience supporting global clinical trials and working with CROs and external vendors.