Clinical Data Specialist

TCS is hiring for EDC Programmer!!!

Job Location – Mumbai

Experience Range – 2 to 8 Years

Skillset Required – Edit Check, Veeva, Rave .

Educational Qualification(s) Required – 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