Clinical Database Programmer

**About the job**:
**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)

**Why Join Us?**
- Be part of a fast-growing consulting firm making a real impact in the healthcare space.
- Work directly with leadership and stakeholders.
- Own and shape the marketing strategy, with full freedom to innovate and experiment.
- Locations we are currently hiring for this role: Pune, Gurgaon, Bangalore, Kochi, Hyderabad, Chennai