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.
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.
Requirements:
Strong knowledge of Clinical Trial Processes.
Hands-on experience with Medidata Rave, Oracle Clinical, Open Clinical.
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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