EDC Programmer - Associate

PuneFull Time
EDC VEEVA RAVE INFORM
Job description

Read and understand the protocol to be able to incorporate the data points into specification
 
Greater transparency with study team regarding timelines and impact of delays on overall eCRF development timelines
 
With the Data Managers, attend and contribute to the study discussions.
 
Lead and Conduct eCRF Design Meetings
 
Document decisions and issues by creating backlog ID in Project Binder during eCRF Design meetings
 
Develop eCRF screens as per the eCRF specification in Veeva Studio
 
Configure SDV/SDR, Safety and Coding within Veeva CDMS tool
 
To review the edit check specification document for clarity and to ensure checks are consistent and appropriate based on e-CRF design
 
 Program new study specific checks, Protocol Deviation checks, Email Checks as per edit check specifications (Should be aware of tips and best practices of Veeva Rules)
 
Validate and Perform developer level testing
 
Provide the UAT details to Validation Team and Study Data Manager
 
Completion of all activities as detailed in the relevant section of the developer checklist.
 
Forwards the Go Live / Training e-mail details to the Study Data Lead(SDL) for inclusion in the Go-Live e-mail
 
 Review and promote SDS, Annotated eCRF, TandE, Blank eCRF ..etc files in eTMF system
 
Confirms all required documents in eTMF system and Project Binder within Veeva
 
Must Have Skill Set
 
Veeva CDMS
 
Rave 
 
Inform

Skills Required
EDC Programmer - Associate
Pharmaceuticals
Bachelor
Full Time, Permanent
Key Skills
  • EDC
  • VEEVA
  • RAVE
  • INFORM
Other Information
GO/JC/2342/2026
Hariharan

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