Clinical Data Management Systems

EDC Expertise  

  • Medidata RAVE - Certified Builder (ID#: MDSO780768178861 – September 2018) 

  • Medrio – Certified Builder 

  • Merative Zelta 

  • Clario 

  • DATATRAK 

  • TrialKit (formerly known as Clinical Studio) 

  • DataFax and iDataFax 

 
Unique Medidata Rave Experience

  • Medidata Rave Builder since 2008 

  • Certified Builder since 2018 

  • Specialty in Oncology; RECIST 1.1 data collection 

 

Database Build & Programming 

  • Develop solutions and recommendations custom forms, folder and matrix structures, edit checks, derivations, custom function specification and implementation 

  • Design, program, validate and maintain clinical databases 

  • Facilitate data integrations and validation of external data via API with external vendors (e.g.: IWRS) 

  • Expert in Rave Classic and Rave EDC 

  • Highly experienced in eCOA and eConsent programming, validation, and implementation (Medrio) 

  • Support Custom Function Programmer via specifications development and user acceptance testing 

  • Primary contact for all CDMS-related questions, issues and initiatives; closely collaborate with Data Management Lead on timelines and deliverables 

 

CDMS Administration 

  • Serve as the senior-level technical subject matter expert by supporting clinical team in Electronic Data Capture (EDC), reporting, and processing platforms 

  • Controlled Documents (SOPs, Work Instructions, Forms, Templates) initial development and maintenance, in adherence with company standards 

  • Controlled Documents Process Review; overall alignment with GCDMP, CDASH and CDISC, recommendations for improvement and efficiency 

  • Develop Global Library of compliant forms; standardize usage across therapeutic areas, indications, platforms, etc. 

  • Mentorship of junior-level Clinical Database Builders and Programmers; provide performance oversight and required training 

 

Sponsor-owned URL Administration 

  • Patient Cloud Administration 

  • Core Configuration set-up and maintenance 

  • Champion for client standards across URLs and vendors