Clinical Development Documentation Specialist

Acts as a key internal support for the Clinical Development Group with respect to preparing and managing technical documents, SharePoint [intranet] sites, and imaging databases.

 

Responsible for the administration of technical documentation and their revision control for a family of products over their lifecycles. This role will include data entry and spreadsheet management for pre-clinical and clinical study results, post-market surveys, and design validations. Will also support IFU (Instruction for Use) change history documentation, scientific literature compilation and case study imaging organization.

 

Specific responsibilities include but are not limited to:

  • Data transfer from survey forms to Excel spreadsheets
  • Routine communication of survey trends and results to team
  • Create and maintain standard data filing system across all projects
  • Extract and export scientific literature from existing EndNote database
  • Perform and maintain literature requests from Edwards eLibrary
  • Prepare change matrix for IFU updates
  • Provide administrative support for IFU approval and other related documents as required
  • Organize case study imaging and convert to appropriate image format as needed
  • Manage master claendars (projects  personnel)  

 

About Edwards:

 

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals worldwide.

 

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life.