Senior Manager, Clinical Data Standards

Role: Senior Manager, Clinical Data Standards, leading global data collection standardization in clinical trials. Responsibilities: develop and govern standardized CRFs, edit checks, and data transfer specs aligned with CDASH and SDTM; oversee external data integrations from labs, biomarkers, and eCOA; ensure collection supports downstream reporting, data traceability, and compliance; lead standards governance, audits, and SOP development; manage EDC database build oversight and vendor compliance. Qualifications: Bachelor's in Life Sciences or related field; 8+ years in Clinical Data Management, with 5+ years in Data Standards and EDC design; expert in Medidata Rave or Veeva CDB; strong knowledge of CDASH/SDTM and regulatory guidelines; experience with complex external data integrations and global trials. Preferred: familiarity with Metadata Repository, DHT data standards, and data analysis tools like SAS or SQL. High-Value: focus on clinical data collection standards supporting biologics or small molecules, with implications for regulatory submissions; experience with EDC platforms and external vendor management in biotech/pharma settings. Location: Gaithersburg, MD or Radnor, PA, hybrid setup.