Katalyst CRO is seeking a skilled Clinical Database Configuration Specialist to manage and configure clinical study databases within EDC systems. Key responsibilities include leading study builds, ensuring compliance, and supporting client workshops. Ideal candidates will have extensive knowledge of clinical trial processes, experience with Medidata Rave and Oracle Clinical, and strong analytical skills. This role offers an opportunity to mentor junior team members in a dynamic environment with a strong focus on process improvement.
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.
Experience in UAT, QC Testing, Functional Documentation.
Knowledge of Integrations and Data Migration.
Strong analytical and problem-solving skills.
Excellent communication and stakeholder management skills.
Team leadership and mentoring experience.
Responsibilities
Lead Study Build / Database Configuration in EDC systems.
Configure Edit Checks, Workflows, Validations.
Gather and translate client requirements into solutions.
Create Specifications / Test Cases / UAT Support.
Support integrations and data transfers with vendors.
Deliver client workshops (remote/on-site).
Manage timelines, budgets, and project deliverables.
Resolve implementation and configuration issues.
Provide status reports to stakeholders.
Mentor junior team members and train new hires.
Drive process improvements and best practices.
Ensure SOP and compliance adherence.
Skills
Clinical Trial Processes
Medidata Rave
Oracle Clinical
OpenClinica
UAT
QC Testing
Integrations
Data Migration
Analytical skills
Communication skills
Stakeholder management
Team leadership
Job description
Katalyst CRO is seeking a skilled Clinical Database Configuration Specialist to manage and configure clinical study databases within EDC systems. Key responsibilities include leading study builds, ensuring compliance, and supporting client workshops. Ideal candidates will have extensive knowledge of clinical trial processes, experience with Medidata Rave and Oracle Clinical, and strong analytical skills. This role offers an opportunity to mentor junior team members in a dynamic environment with a strong focus on process improvement.