EDC Programmer

Gratitude Inc

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2 days ago

EDC Programmer

4-12 Year(s)

Mumbai, Bengaluru, Hyderabad

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Job Description

Key Skills

Veeva CQL Handson experience as programmer in eCOA or Rave eDC Study Build Programming with expertise in Custom Functions

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Job Title : EDC Programmer – Veeva CDMS

Location: Mumbai / Pune / Bangalore / Hyderabad
Experience: Relevant EDC Programming / Clinical Data Management Experience
Work Mode: Work From Office
Shift: General Shift

Job Description

We are hiring an experienced EDC Programmer to support clinical data management activities, database design, eCRF development, programming, configuration, testing, validation, and post-go-live changes using Veeva CDMS and Veeva Studio.

The ideal candidate should have strong experience in eCRF development, edit check programming, SDV/SDR, safety and coding configuration, along with exposure to clinical trials and international BPO operations.

Key Responsibilities

Read and understand clinical study protocols and incorporate data points into eCRF specifications.
Develop eCRF screens in Veeva Studio according to approved specifications.
Configure SDV, SDR, Safety, and Coding within Veeva CDMS.
Lead and participate in eCRF design meetings with Data Managers and study teams.
Review edit check specifications and ensure checks are appropriate and consistent with eCRF design.
Program study-specific checks, Protocol Deviation checks, and Email Checks using Veeva Rules.
Perform developer-level validation, unit testing, and troubleshooting.
Provide UAT details to the Validation Team and Study Data Manager.
Maintain developer checklists and required project documentation.
Review and promote SDS, Annotated eCRF, T&E, Blank eCRF, and related documents in the eTMF system.
Perform impact analysis and implement post-go-live change requests.
Modify eCRF screens and update/create study-specific rules as required.
Perform unit testing for eCRF changes and edit checks.
Support testing, validation, database design, programming, and data transfers.
Perform quality control procedures and ensure compliance with SOPs and regulatory requirements.
Provide technical expertise and support to the Clinical Data Management team.
Participate in client/study meetings and provide regular project status updates.
Identify and recommend process improvements.
Support knowledge transfer and sharing of best practices.

Required Skills

Strong hands-on experience with Veeva CDMS and Veeva Studio.
Experience in EDC programming and eCRF development.
Knowledge of SDV, SDR, Safety, and Coding configuration.
Experience programming edit checks and Veeva Rules.
Understanding of clinical trial protocols and Clinical Data Management.
Experience with database design, validation, testing, and data transfers.
Strong analytical and problem-solving skills.
Good written and verbal communication.
Strong documentation and stakeholder management skills.
Knowledge of SOPs, regulatory requirements, and clinical data management processes.
Ability to work effectively with Data Managers, Study Data Leads, Validation Teams, and clients.

Qualifications

Bachelor's degree is mandatory.
Bachelor's degree in Scientific / Technical discipline is preferred.
Relevant experience in EDC Programming / Clinical Data Management.
International BPO experience is mandatory.

Important Notes

Former TCS employees are not eligible for this position.
International BPO experience is mandatory. Candidates without international BPO experience should not be considered.
Candidates must currently be located in Mumbai, Pune, Bangalore, or Hyderabad.
Graduation is compulsory.
Ex TCS Employees can't apply
PAN and DOB are required for profile creation

Role

Clinical Research Associate/Scientist

Timings

Day Shift (Permanent)

Industry

Medical / Healthcare / Hospital

Work Mode

Work from office

Process

Non-Voice

Functional Area

Medical Professional / Healthcare Practitioner / Technician

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