Clinical Data Management - South Plainfield, United States - Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Verified Company

South Plainfield, United States

3 days ago

Posted by:

Mark Lane

beBee recruiter

Roles & Responsibilities:

Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies
Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules
Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming
Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
Design "smart " listings and studyspecific processes for effective data review, query issue and resolution
Perform coding of adverse events, medical conditions and medications.
Perform SAE reconciliation
Lead and perform prelock and data lock tasks
Prepare training materials and user guides for EDC data collection tools, deliver user training
Design, generate, and review status metric reports, identifying and communication trends as needed
Provide input to crossfunctional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
Provide study specific training for team members and end users, as appropriate
Lead large and complex projects
Lead client and team meetings as required
Interact with sponsors and manage vendors for complex studies
Present at sales and marketing meetings for prospective clients
Develop SOPs and manuals