Medrio EDC Consultant / Medrio Developer

IT ENGAGEMENTS INC
San Jose, United States of America
4 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Senior

Job location

Remote
San Jose, United States of America

Tech stack

API
Agile Methodologies
Clinical Data Management
Clinical Data Repository
System Configuration
Data Validation
Python
Oracle Applications
SAS (Software)
Software Deployment
SQL Databases
System Testing
Information Technology
Enterprise Integration
Veeva
ServiceNow

Job description

We are seeking an experienced Medrio Developer with strong expertise in clinical data management and EDC system configuration to support clinical trial operations at our client. The ideal candidate will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and study teams to design, configure, validate, and maintain studies within the Medrio Platform. Key Responsibilities

  • Configure and develop clinical studies in the Medrio EDC platform.
  • Design eCRFs, edit checks, visit structures, workflows, and custom validations.
  • Perform UAT, system testing, and production deployment activities.
  • Support integration activities between Medrio and external clinical systems.
  • Collaborate with Clinical Data Managers and study teams to gather requirements.
  • Ensure compliance with GCP, FDA 21 CFR Part 11, and CDISC standards.
  • Create and maintain study documentation:
  • Functional Specifications
  • Validation Documents
  • User Guides
  • SOPs
  • Provide production support and resolve system issues during study conduct.
  • Participate in study build reviews, audits, and inspections., Job Description: Job Title: ServiceNow Developer Location: Santa Clara, CA (Hybrid) Must Have Must be a ServiceNow Certified System Administrator CSA Must possess at least…
  • 7 days ago

Requirements

  • Strong experience with Medrio Platform EDC configuration and administration.
  • Knowledge of Clinical Data Management processes.
  • Experience in:
  • eCRF design
  • Edit checks
  • Query management
  • Data validation
  • Understanding of:
  • CDISC standards (SDTM/CDASH)
  • GCP
  • FDA regulations
  • Familiarity with SQL and data reconciliation processes.
  • Experience working in pharma or CRO environments.
  • Strong communication and stakeholder management skills., * Bachelor's degree in Life Sciences, Computer Science, Pharmacy, or related field.
  • 3 7+ years of experience in clinical EDC platforms.
  • Prior experience supporting oncology or global clinical trials.
  • Exposure to Agile delivery methodologies.
  • Certification or hands-on experience with:
  • Medrio
  • Medidata Rave
  • Oracle Inform
  • Veeva Clinical platforms

Nice-to-Have Skills

  • API/integration knowledge
  • SAS or Python exposure
  • Clinical reporting/dashboard experience

About the company

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