Clinical Data Manager

Our client is a leading organization in the antibody driven Immuno-oncology space with a proven platform that has garnered multiple hundred-million dollar industry partnerships to drive their 5+ clinical trials. This company has multiple wholly owned assets within Ph1 and Ph2 clinical studies and are looking for a Clinical Data Manager to who will be responsible for the oversight of all aspects of clinical trial data management from start-up through closeout.

Responsibilities:

• Manage clinical study data for outsourced early-stage trials (phase I-II), including project and vendor oversight.
• Serve as a liaison with CROs, third-party data vendors, and EDC vendors
• Oversees the creation and approval of Data Management study documentation including, but not limited to, eCRFs, clinical database specifications, CCGs, DMPs, data handling guidelines, data review plans, data transfer specifications/agreements, external vendor data reconciliation plans, and SAE reconciliation plans
• Reviews clinical data listings and reports on performance and quality; review clinical data within studies and across programs for trend analysis

Qualification:

• Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study
• Minimum of 3 years of relevant clinical data management experience within the Pharma, Biotech, or CRO industry
• Oncology or immunology/inflammation experience required
• Familiarity with advanced Excel functions, SAS, and SQL is a plus
• Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC) (Oracle Inform and Medidata Rave), clinical data management systems, and industry wide coding dictionaries (MedDRA and WHODrug)