Senior Clinical Database Pogrammer

1 week ago

Gurgaon, Haryana, India ProcDNA Full time ₹ 10,00,000 - ₹ 12,00,000 per year

About ProcDNA
ProcDNA is a global rocket ship in life sciences consulting, helping pharma and biotech companies accelerate impact across Commercial Analytics, R&D, and Clinical Data Management. We fuse design thinking with cutting-edge technology to deliver game-changing solutions - from clinical trial data capture, cleaning, and regulatory submissions to AI-powered R&D acceleration and commercial strategy. Since our launch during the pandemic, we've grown into a passionate team of 350+ across 8 offices worldwide, all learning and innovating together. Here, you won't be stuck in a cubicle - you'll be shaping the future of life sciences alongside brilliant minds. Ready to join our epic growth journey?

What We Are Looking For
We are seeking a Senior Programmer with strong hands-on experience in EDC platform such as Medidata RAVE. The ideal candidate will have a solid understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. You will play a key role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle.

Responsibilities
eCRF & EDC Development: Interpret clinical trial protocols to design eCRFs and build databases using Medidata RAVE. Configure systems and implement edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS.

Review & Validation: Conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components.

Amendments & Issue Resolution: Manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments.

Post-Go-Live & Coordination: Handle migrations, RFCs, and post-go-live activities. Generate sponsor reports (JReview, SAS, BOXI), act as DB Coordinator across trials, and mentor junior team members.

Must have
EDC Expertise: 6 to 8 years of hands-on experience with Medidata RAVE EDC Platform. Strong skills in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE).

Clinical & Technical Knowledge: Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs.

Sound knowledge of ICH GCP & CDISC/CDASH standards

Experience in creating and maintaining the global libraries

Quality & Communication: High attention to detail with strong adherence to ICH GCP and clinical data standards. Excellent written and verbal communication skills for effective team and sponsor collaboration.

Educational Background: BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream. Consistent academic performance with 60% or above in 10th, 12th, and graduation is mandatory.

Medidata certified Study Builder (SDBE) is essential.

Skills: clinical data,ecrf,medidata rave

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