Lead Clinical Data Engineer – EDC Systems

Katalyst CRO; Austin (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO in Austin, Texas is looking for a Database Configuration Lead to design and build clinical study databases using EDC/CDM platforms. The ideal candidate will have strong knowledge of clinical trial processes, hands-on experience with Medidata Rave, Oracle Clinical, and OpenClinica, and proven team leadership abilities. This role involves mentoring junior staff, managing project deliverables, and ensuring compliance with regulatory standards. Excellent communication skills and problem-solving abilities are essential for delivering client solutions.

Qualifications

• 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.

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.

Skills

Clinical Trial Processes

Medidata Rave

Oracle Clinical

OpenClinica

Analytical skills

Stakeholder management

Team leadership

Job description

Katalyst CRO in Austin, Texas is looking for a Database Configuration Lead to design and build clinical study databases using EDC/CDM platforms. The ideal candidate will have strong knowledge of clinical trial processes, hands-on experience with Medidata Rave, Oracle Clinical, and OpenClinica, and proven team leadership abilities. This role involves mentoring junior staff, managing project deliverables, and ensuring compliance with regulatory standards. Excellent communication skills and problem-solving abilities are essential for delivering client solutions.