3.0 - 5.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We&aposre a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won&apost be stuck in a cubicle - you&aposll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey What we are looking for We are seeking a Programmer Analyst with strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. 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. What you will do eCRF & EDC Development: Interpret clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. 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: 3 to 5 years of hands-on experience with at least one EDC platform Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). 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. 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. Show more Show less

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Clinical Research Associate Ayur.AI

1.0 - 5.0 years

0 Lacs

chennai, tamil nadu

On-site

As a Clinical Research Assistant, you will be responsible for supporting the daily operations of our longitudinal clinical trials, focusing on Continuous Glucose Monitoring (CGM), lab testing, gut microbiome analysis, and remote consultations with physicians. Your role will be crucial in coordinating participant involvement, ensuring accurate data collection, and maintaining clear communication among all stakeholders including patients, labs, physicians, and the internal research team. Your key responsibilities will include coordinating participant appointments for CGM setup, lab tests, stool sample collection, and virtual consultations. You will also be required to provide clear instructions and support to participants for app usage and test procedures. Additionally, you will monitor and collect data from wearable CGM devices and study-related apps, ensuring timely entry and validation of participant data in study databases or CRFs. Identifying and reporting data inconsistencies or protocol deviations to the study coordinator or PI will also be part of your duties. You will act as a liaison between participants, clinical labs, logistics partners, and physicians, maintaining regular, empathetic communication with participants to encourage adherence and resolve concerns. Coordinating specimen shipment and tracking with third-party labs will also fall under your responsibilities. Moreover, you will be expected to maintain accurate participant records in accordance with GCP and IRB protocols, including participant information sheets, consent forms, and data tracking tools. To excel in this role, you should possess a Bachelor's degree in a health-related field, with experience in clinical research or healthcare setting preferred. Knowledge of lab logistics, biospecimen handling, CGM devices, and mobile health tracking tools will be advantageous. Proficiency in using spreadsheets, EDC platforms, or research data systems, along with strong organizational, communication, and attention to detail skills, will be essential. You should also be able to work independently, manage time efficiently, and multitask across projects, while comfortably working with patients remotely and explaining technical processes in simple terms. A proactive, empathetic, and collaborative attitude will be key to your success in this role.,

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Clinical Data Svs Analyst / Clinical Database Developer Relyon Resources Pvt Ltd

3.0 - 5.0 years

6 - 8 Lacs

Bengaluru

Work from Office

Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred. Extensive experience in database design, edit check programming, custom function programming and unit testing. Required Candidate profile Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Posted 3 months ago

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