Hands-on experience with Medidata Rave, Oracle Clinical, OpenClinic
Expertise in study database build & configuration
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
Experience in team leadership and mentoring
Responsibilities
Lead the design and configuration of clinical study databases in EDC systems
Configure edit checks, workflows, and validations
Translate client requirements into technical solutions
Create specifications, test cases, and support user acceptance testing
Support integration and data transfer with external vendors
Deliver client workshops both remotely and on-site
Manage project timelines, budgets, and deliverables
Resolve implementation and configuration issues during database build
Provide regular status updates to stakeholders
Mentor junior team members and train new hires
Drive improvements and best practices in process adherence
Ensure compliance with standard operating procedures
Benefits
Opportunity for professional growth and skill development
Mentoring and training opportunities
Exposure to cutting-edge technologies in clinical data management
Work with a collaborative team environment
Flexibility in delivering workshops remotely and on-site
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
