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.
Ardea Biosciences is searching for a Manager, Data Management to join the team.
The overall responsibility will be 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.
Primary Duties and Responsibilities
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.