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Clinical Data Associate III
Ref No.: 19-07825
Location: Cambridge, Massachusetts
Join a global biopharmaceutical company committed to healthcare solutions from prevention to treatment.  They turn scientific discoveries into medicine to improve human health.  Every day they dedicate their most important resource, the people, to support patients and families through their health journey.
 
A. JOB SUMMARY: 
  • This position is a technical individual dedicated to operational activities related to the technical development, implementation, and maintenance of the Sanofi Genzyme Global Rare Disease Registry web-based electronic data capture (EDC) and reporting technology platform.  This position is part of the DM Technical Team which is a sub-group of the overall Registry Data Management group and works alongside the DM Quality team within Data Management.
  • This position is responsible for coordinating and gathering technical requirements for CRF changes from Registry team stakeholders related to the Rare Disease Registry web-based EDC and reporting technology platform.
  • This position is responsible for creating and maintaining technical requirements and specifications related to the Rare Disease Registry web-based EDC and reporting technology platform.
  • This position is responsible for user acceptance testing (UAT) and associated documentation for changes implemented in the Rare Disease Registry web-based EDC and reporting technology platform.
  • This position is responsible for collaborating with the technical vendor for the Rare Disease Registry web-based EDC and reporting technology platform project meetings, changes, etc.
 
III – KNOWLEDGE, SKILL FORMAL EDUCATION & EXPERIENCE REQUIREMENTS (Minimum requirements for assignment to this job)
 
A. Knowledge and Skills:
  • Clinical data management experience (CRF design, data collection, data review, query management)
  • Experience with EDC systems
  • Clinical database experience including eCRF/database design and development, system edit check design and development, writing UAT scripts, and conducting UAT
  • Good working knowledge of software development life cycle (SDLC) and change management
  • Good working knowledge of industry data standards (e.g., CDASH, SDTM) and how to apply them to CRF design and database development
  • Ability to work with reporting/analytical tools (e.g., Business Objects) to manipulate data and produce metrics
  • Strong organizational skills and attention to detail
  • Strong team work and collaboration skills
  • Strong communication skills (verbal and written)
  • Experience with training and developing training materials
  • Good working knowledge of International Regulations / Guidelines / Good Clinical Practices pertaining to the pharmaceutical industry standards and practices
 
B. Formal Education and Experience Required:
  • Bachelor’s degree in related science/technical discipline
  • At least 4 years of clinical data management/database development experience in the pharmaceutical/biotechnology industry
  • At least 2 years of experience with EDC systems, preferably Medidata Rave
  • At least 2 years of experience with EDC requirements, database development, user acceptance testing, and implementation of eCRF study builds
 
C. Knowledge and Skills Desirable but Not Essential:
  • Experience with Medidata Rave EDC
  • Completion of Medidata Rave Study Design and Build Essentials training coursework
  • Experience with CRF migrations within EDC systems
  • Experience with validation of computer systems