Senior Clinical Database Programmer – EDC/CDM Lead

Katalyst CRO

Boulder (CO)

On-site

Full time

14 days+

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Job 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 issuesProvide 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
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