Life Science : EDC Programmer : Veeva Studio : Max 12 LPA : Apply

Hi,

We are hiring for one of India's leading IT & consulting organizations for the position of EDC Programmer Role

Summary

An EDC Programmer is a specialized IT professional in clinical research who designs, builds, and maintains digital databases (eCRFs) used to collect patient data during clinical trials. They ensure data accuracy, configure validation checks to identify errors, and ensure compliance with regulatory standards

• To Apply for above EDC Programmer, WhatsApp 'Hi' @ 9519459922

• When Asked For The job Code, Type: Job Code # 6

Key Skills

• At least 4 years of experience as EDC Programmer
• Minimum 1 year of experience in Developing eCRF screens as per the eCRF specification in Veeva Studio.
• Clinical Data Management & Regulatory Knowledge
• Implemented SDV (Source Data Verification) and SDR (Source Data Review) workflows within Veeva CDMS
• Configured Safety (Adverse Event handling) and Medical Coding (e.g., MedDRA/WHO Drug)
• Bachelors Degree in a Scientific or Technical Discipline

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
• Review the edit check specification document for clarity and ensure checks are consistent and appropriate based on eCRF design
• Program new study-specific checks, protocol deviation checks, and email checks as per edit check specifications (follow Veeva rules best practices)
• Validate and perform developer-level testing
• Provide UAT details to Validation Team and Study Data Manager
• Complete all activities as detailed in the relevant section of the developer checklist
• Forward Go-Live / training email details to the Study Data Lead (SDL) for inclusion in the Go-Live email
• Review and promote SDS, annotated eCRF, TandE, blank eCRF, etc. files in eTMF system
• Confirm all required documents in eTMF system and Project Binder within Veeva
• 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.