5-7 years of experience in clinical trial data management
Proficient in Medidata Rave, Oracle Clinical, and OpenClinic
Expertise in designing and configuring study databases
Familiarity with CDISC standards and data management
Experience in User Acceptance Testing (UAT) and quality control
Knowledgeable in data integration and migration
Strong analytical skills with problem-solving capabilities
Demonstrated ability to lead and mentor teams
Responsibilities
Lead the configuration of study databases within EDC systems
Set up and customize edit checks, validations, and workflows
Translate client specifications into effective database solutions
Develop comprehensive specifications, test cases, and support User Acceptance Testing
Facilitate seamless data transfers and integrations with vendor systems
Conduct client workshops, both remotely and on-site
Manage project timelines, budgets, and deliverables
Address and resolve issues during database implementation and configuration
Maintain regular communication with stakeholders through status reporting
Mentor junior team members and support the onboarding of new staff
Drive process improvements and uphold standard operating procedures (SOP) adherence
Benefits
Collaborative work environment that encourages professional growth
Opportunity to lead significant projects with client exposure
Engagement in innovative practices to enhance data management
Access to continuous learning and development programs
Flexible work arrangements to promote work-life balance
Full 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 issues
Provide 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, OpenClinic
Study database build & configuration expertise
Understanding of CDISC / Data Standards / Data Management
