Clinical Data Manager at Katalyst Healthcares & Life Sciences

Responsibilities : Clinical Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies. Interact and manage relationships with other functional areas to ensure high quality data management activities. Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines) Participate in User Acceptance Testing Activities for the applicable Data Collection Tools Perform Quality Control for data completeness and accuracy. Participate in and support data cleaning, query generation and resolution and review of medical coding as needed. Requirements: 5+years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience 3+ years managing vendor relationships/partnerships in a global environment. Must have advanced knowledge of Data Management processes and systems. Oncology experience required. Solid understanding of CDISC standards required. Data Visualization Tool experience preferred. Experience using standardized medical terminology, including but limited to MedDRA and WHO Drug. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.