Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations. Design, build, and configure clinical study databases in EDC/CDM platforms.
Numbers & Facts
Location
San Francisco, CA
Description
Job Description:
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, OpenClinica.
Study database build & configuration expertise.
Understanding of CDISC / Data Standards / Data Management.