Clinical Database Programmer

About ProcDNA

ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isn't just encouraged, it's ingrained in our DNA.

What We Are Looking For

Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. We are seeking an individual who not only possesses the requisite expertise but also thrives in a fast-paced environment.

What You’ll Do

• Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system and Setup Core Configurations.
• Implementing the Dynamic rules as per the Sponsor requirements.
• Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification.
• Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC.
• Incorporate internal feedback and update programs as required.
• Incorporate Sponsor Acceptance Testing (SAT) feedback.
• Maintain and update the eCRFs and their components as required for protocol amendments or required metadata updates.
• Perform second/final review for peer deliverables.
• Create RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC).
• Incorporate RAVE Configuration Specification.
• Facilitate Internal Configuration Review Meeting (ICRM).
• Revise and update eCRF booklet, DVS and Configuration Specification.
• Facilitate Sponsor Acceptance Meeting (SAM).
• Handle issues related to QC/UAT/PROD and tracking issues to closer.
• Review of the DVS for clarity and to ensure checks are consistent and appropriate based on eCRF design. Provide feedback to DVS author.
• Support CRO trial activities, including CRF annotation, database setup, specification generation, Clinical view settings, and dataset comparison.
• Create reports as per the Sponsor specification document using JReview, SAS, BOXI.
• Estimate and perform migration process for Post Go-Live studies (handling RFCs).
• Performe DB Coordinator role for multiple trials.
• Mentor new hires in CRO and EDC activities.

Must Have

• Protocol reading and understanding
• Expertise in ‘Critical Data Point Strategy (CDPS) or SDV’ implementation.
• Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials.
• Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information.
• Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information.
• Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc.
• Project management skills: Managing the document development process and meeting timelines.
• People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only).
• Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio
• B.E./B.Tech - Computer Science-based courses or Circuit Branches)
• M.Sc./ MCA in the stream of Computer Science
• B.Sc./ BCA in the stream of Computer Science)