EDC Programmer

2 days ago

Delhi, India Tata Consultancy Services Full time
TCS is hiring for EDC Programmer Role

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

Post Go Live Changes -

- Review the change control form and understand the changes requested- Perform impact analysis of the change request and suggest different methods of handling the change- Perform eCRF Screen changes in Veeva as requested with appropriate method- Unit Test eCRF Screen changes and edit checks in Veeva CDMS- Perform study specific rules updates/creation as per the specification updates in Veeva- Receive and implement feedback from the execution of the test scripts- Review the changes in PPT environment for existing/new, frozen/locked etc subjects- Completion of all activities as detailed in the relevant section of the Post Go-Live checklist

GENERIC RESPONSIBILITIES -

- Perform and/or initiate comprehensive data management tasks, pertaining to Database design, programming, and validation and Data transfers.- Perform quality control procedures for relevant activities.- Provide Clinical Data Management team with technical expertise.- Develop and maintain good communication and working relationships with DM team.- Perform tasks/activities as communicated by customer, SDM or Alliance Manager.- Create/review/update the Data Management Plan documents.- Attend/Conduct telephone conferences/meetings as required.- Adherence to SOPs/Regulatory requirements/project specific guidelines.- Escalation of identified unresolved issues to Customer/SDM/ Alliance Manager.- Provide inputs/status reports on monthly basis during the life cycle of the project.- Proactively propose process improvements.- Knowledge transfer & sharing experience/lessons learned.

Best Regards,

Megha Dixit

TCS - HR

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