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
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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