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

Posted 4 weeks ago

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Clinical Programmer - II (Rave) Syneos Health

4.0 - 6.0 years

8 - 12 Lacs

Hyderabad

Hybrid

Immediate Joiners preferable. Role & responsibilities •Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. •Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports. •Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. •Ensures quality deliverables by providing review of study level core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. •Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders. Preferred candidate profile 3-5 years experience of Medidata Rave Experience in DB build, eCRF form designing, Edit Checks programming, Migrations, Publish checks Understanding of Protocol Interpretation. Simple to moderate Custom functions Strong Communication.

Posted 1 month ago

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Clinical DB Designer Iqvia Biotech

5.0 - 8.0 years

5 - 8 Lacs

Bengaluru, Karnataka, India

On-site

Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req

Posted 2 months ago

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