EDC Programmer

3 weeks ago

Mumbai, India Tata Consultancy Services Full time

Job description


TCS is hiring for EDC Programmer

Job Location Mumbai

Experience Range 5 to 12 Years

Skillset Required EDC, Veeva, Rave

Education

UG: Any life science Postgraduate, B.Pharma in Any Specialization

PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization


Interested candidates are requested share updated CV with below details on the mail id s.laharika@tcs.com


Key Responsibilities

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


Regards

Laharika - TCS HR

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