Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations.
Key Responsibilities:
Lead Study Build / Database Configuration in EDC systems
Configure Edit Checks, Workflows, Validations
Gather & translate client requirements into solutions
Create Specifications / Test Cases / UAT Support
Support integrations & data transfers with vendors
Deliver client workshops (remote/on-site)
Manage timelines, budgets & project deliverables
Resolve implementation / configuration issues
Provide status reports to stakeholders
Mentor junior team members / train new hires
Drive process improvements & best practices
Ensure SOP / compliance adherence
Required Skills:
Strong knowledge of Clinical Trial Processes
Hands-on experience with Medidata Rave, Oracle Clinical, OpenClinica
Study database build & configuration expertise
Understanding of CDISC / Data Standards / Data Management
UAT, QC Testing, Functional Documentation
Integrations / Data Migration knowledge
Strong analytical & problem-solving skills
Excellent communication & stakeholder management
Team leadership / mentoring experience
Numbers & Facts
Location
Boulder, CO
Skills
Acceptance Testingunmatched
Analysis Skillsunmatched
Best Practicesunmatched
Budget Managementunmatched
Clinical Dataunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Data Managementunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Configuration Managementunmatched
Customer/Client Researchunmatched
Data Collectionunmatched
Data Managementunmatched
Data Migrationunmatched
Database Administrationunmatched
Database Programmingunmatched
Documentationunmatched
Electronic Data Capture (EDC)unmatched
Functional Testingunmatched
Maintain Complianceunmatched
Mentoringunmatched
Oracleunmatched
Problem Solving Skillsunmatched
Procedure Implementationunmatched
Process Improvementunmatched
Quality Controlunmatched
Reporting Skillsunmatched
Requirements Managementunmatched
Status Reportsunmatched
Systems Administration/Managementunmatched
Team Lead/Managerunmatched
Test Caseunmatched
Time Managementunmatched
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