We are seeking an influential Clinical Data Management to join our cohesive team at Katalyst Healthcares & Life Sciences in South Plainfield, NJ.
Growing your career as a Full-Time Clinical Data Management is a remarkable opportunity to develop indispensable skills.
If you are strong in communication, project management and have the right attitude for the job, then apply for the position of Clinical Data Management at Katalyst Healthcares & Life Sciences today!
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 study-specific processes for effective data review, query issue and resolution
- Perform coding of adverse events, medical conditions and medications.
- Perform SAE reconciliation
- Lead and perform pre-lock 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 cross-functional 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
Education & Experience:
- Minimum 9 years of experience in Clinical Data Management
- Minimum BS in a scientific or health related field or equivalent
- Previous experience working for a CRO required
- Knowledge of medical terminology and pharmaceutical notation
- Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
- Excellent organizational and time management skills
- Strong collaboration and leadership skills
Benefits of working as a Clinical Data Management in South Plainfield, NJ:
● Excellent benefits
● Opportunities to grow
● Competitive salary
No CV Required
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