
EDC Programmer
4 days ago
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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