Clinical Data Specialist

EDC Programmer!!!

Mumbai

2 to 8 Years

Edit Check, Veeva, Rave

Any Life Science Graduate

Interested can share their cv on Babeeta.shahi@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