Hands-on experience with Medidata Rave, Oracle Clinical, OpenClinica
Study database build & configuration expertise
Understanding of CDISC, Data Standards, Data Management
Experience with 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 and database configuration in EDC systems
Configure edit checks, workflows, and validations
Gather and translate client requirements into solutions
Create specifications, test cases, and provide UAT support
Support integrations and data transfers with vendors
Deliver client workshops, both remote and 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 adherence to SOP and compliance
Benefits
Opportunity to lead and shape clinical study configurations
Collaborative environment with emphasis on mentorship
Engagement with clients through workshops and consultations
Involvement in process improvement initiatives
Potential for remote and on-site work flexibility
Full Job 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.
