Medrio EDC Consultant / Medrio Developer

IT Engagements

San Jose, CA(remote)

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JOB DETAILS

SALARY

$60–$65

SKILLS

Acceptance Testing, Agile Programming Methodologies, Application Programming Interface (API), Biology, Biostatistics, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Information Systems, Clinical Support, Clinical Trial, Code of Federal Regulations, Communication Skills, Computer Science, Consulting, Contract Research Organization (CRO), Data Quality, Documentation, Electronic Data Capture (EDC), FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), Knowledge Management, Maintain Compliance, Oncology, Operational Support, Oracle, Pharmacy, Problem Solving Skills, Production Support, Python Programming/Scripting Language, Reconciliation, Reporting Dashboards, Requirements Management, SQL (Structured Query Language), Standard Operating Procedures (SOP), System Test, Systems Administration/Management, Validation Documentation

LOCATION

San Jose, CA

POSTED

1 day ago

Greetings from IT Engagements

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

Role: Medrio EDC Consultant / Medrio Developer (Contract Role)

Location: Remote

Job Summary

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.

Required Skills

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.

Preferred Qualifications

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

Thanks and Regards

Divya Kumari

divya@itengagements.com

Medrio EDC Consultant / Medrio Developer

IT Engagements

San Jose, CA(remote)

About the Company

IT Engagements

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