Role – EDC Programmer
Location - Mumbai, Pune, Bangalore, Indore, Ahmedabad
Qualifications - BACHELORS’ DEGREE IN A SCIENTIFIC / TECHNICAL DISCIPLINE IS
PREFERABLE
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
