Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. We are now Hiring a Manager, Data Management to manage our dynamic Team.
Ardea Biosciences is seeking a Manager, Data Management to manage the Data Management of one or more clinical programs in phase 1-3 studies. The successful candidate will manage CROs, technology vendors, and liaise with Clinical Operations, Finance and Project Management.
For more Information on Job Responsibilities and Requirements - Interested parties please apply today at: www.ardeabio.com/careers
• Acts as a primary liaison to CROs and/or technology vendors for one or more clinical studies, providing Company representation and for adherence to project scope, deliverables and timetables.
• Tracks and reports metrics for data status.
• Interacts with Clinical Operations to address data collection/cleaning issues on clinical studies.
• Works with CROs to complete Data Management documents, CRFs, and other study documentation.
• Organizes and runs meetings and teleconferences for Data Management issues for clinical studies.
• Coordinates Data Management project timelines with Project Management and Clinical Operations to meet critical milestones; and/or escalates issues that may jeopardize timelines and deliverables.
• Liaises with other functional areas, such as Biostatistics and Clinical Operations, in order to accurately coordinate Data Management activity.
• Coordinates with Project Management to track the Data Management progress on studies against the projected timeline.
• Coordinates with Finance to track the financial status against budget.
• Maintains up-to-date knowledge of data management and clinical data technology.
• Maintains clinical study files per ICH guidance.
• Trains Clinical Data Managers.
• Other duties as may be necessary.