Hands-on experience with Medidata Rave, Oracle Clinical, or OpenClinica
Expertise in study database build and configuration
Understanding of CDISC, data standards, and data management
Experience with UAT, QC testing, and 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 remotely 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 SOP compliance adherence
Benefits
Opportunity for professional development and mentorship
Work with leading clinical trial management systems
Engage in a dynamic, client-focused environment
Participate in various projects across different therapeutic areas
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.
