Tata Consultancy Services | EDC Programmer | mumbai

1 month ago

mumbai, 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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