EDC Programmer
Gratitude IncEDC Programmer
Job Description
Key Skills
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Job Title : EDC Programmer
Job Description:
The EDC Programmer will be responsible for developing and configuring electronic Case Report Forms (eCRFs) and study-specific programming requirements within Veeva CDMS. The role involves understanding clinical study protocols, translating data points into eCRF specifications, developing eCRF screens in Veeva Studio, configuring SDV/SDR, Safety and Coding, programming edit checks and protocol deviation checks, and performing developer-level validation and testing. The EDC Programmer will also support post-Go-Live changes, impact analysis, eCRF modifications, edit-check updates, testing, documentation, and data management activities while ensuring adherence to SOPs, regulatory requirements, and project-specific guidelines.
Key Responsibilities:
Read and understand study protocols and incorporate required data points into specifications.
Participate in study discussions with Data Managers and contribute to eCRF design activities.
Lead and conduct eCRF Design Meetings and document decisions/issues.
Develop eCRF screens as per specifications using Veeva Studio.
Configure SDV/SDR, Safety, and Coding within the Veeva CDMS tool.
Review edit-check specifications for clarity, consistency, and appropriateness.
Program study-specific checks, Protocol Deviation checks, and Email Checks using Veeva Rules.
Perform validation and developer-level testing.
Provide UAT details to the Validation Team and Study Data Manager.
Complete activities specified in developer checklists.
Review and promote SDS, Annotated eCRF, TandE, Blank eCRF, and other relevant files in the eTMF system.
Confirm required documentation in the eTMF system and Project Binder.
Perform impact analysis and implement post-Go-Live change requests.
Perform eCRF screen changes, unit testing, and edit-check updates in Veeva CDMS.
Review changes in the PPT environment for existing/new and frozen/locked subjects.
Perform database design, programming, validation, and data-management activities.
Perform quality-control procedures and provide technical expertise to the Clinical Data Management team.
Maintain effective communication with DM teams and stakeholders.
Adhere to SOPs, regulatory requirements, and project-specific guidelines.
Escalate unresolved issues and provide regular project status updates.
Proactively identify process improvements and support knowledge transfer.
Qualifications:
Graduation is compulsory.
Bachelor's degree in a Scientific or Technical discipline is preferable.
International BPO experience is mandatory.
Important Eligibility:
Candidates must currently be based in Mumbai. CVs of candidates not in Mumbai should be rejected.
International BPO experience is mandatory.
Graduation is compulsory.
Former TCS employees / TCS rehires are not eligible.
PAN and DOB are required for profile creation.
Hands-on experience with Veeva Studio / Veeva CDMS and eCRF development is required for the role.
Role
Clinical Research Manager
Timings
Flexible (Permanent)
Industry
BPO
Work Mode
Work from office
Process
Non-Voice
Functional Area
Medical Professional / Healthcare Practitioner / Technician
Note: Myglit doesn't charge any money from candidates. If you have been asked to pay money to get this job then report to us immediately at support@myglit.com.
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