Clinical Database Programmer

Rave, Oracle Inform, Veeva Studio ProcDNA is a global rocket ship in life sciences consulting where design thinking meets cutting-edge technology. We deliver transformative solutions across Analytics, Technology, and Clinical, helping our clients drive smarter decisions and better patient outcomes. We're a passionate team of 350+ 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. Ready to join our epic growth journey? 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 youll do Protocol reading and understanding 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 Experienced in writing the Data Validation Specification (DVS) 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 studiesor other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must have 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). What youll do Protocol reading and understanding 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 Experienced in writing the Data Validation Specification (DVS) Create, test,and maintain trial-specificplausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Incorporate Sponsor Acceptance Testing (SAT) feedback Maintain and update the eCRFs and theircomponents as required for protocol amendments or required metadata updates Perform second/final review for peer deliverables Creating RAVE System Configuration Specification (Core config, Report Config, e-learning config, Appendix config & coding spec in RAVE or other EDC) Incorporate RAVE Configuration Specification Facilitating Internal Configuration Review Meeting (ICRM) Revise and update eCRF booklet, DVS and Configuration Specification Facilitating Sponsor Acceptance Meeting (SAM) Handling issues related to QC/UAT/PROD and tracking issues to closer A seasoned resource on Double Data Entry (DDE) Expertise in Critical Data Point Strategy (CDPS) or SDV implementation 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 Creating reports as per the Sponsor specification document using JReview, SAS, BOXI Estimate and perform migration process for Post Go-Live studies (handling RFCs) Performing DB Coordinator role for multiple trials Mentor new hires in CRO and EDC activities Certified Medidata Study Builder (SDBE), Oracle - InForm/ Central Designer, Veeva Studio Educational Qualifications 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) Class 10th+ 12th/PU/ + 3 years or equivalent Academic score throughout should be > 60% is mandatory