Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations. Role Summary: Design, build, and configure clinical study databases in EDC/CDM platforms.
Numbers & Facts
Location
Boulder, CO
Description
Role Summary:
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