Clinical Data Management

1 month ago


South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

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
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