Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
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 searching for a Manager, Data Management to join the Ardea 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
*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.
*Bachelor's Degree with a science major preferred.
*6+ years of Data Management and overall drug development in the pharmaceutical/biotechnology industry.
*Strong experience in management of CROs.
*Previous experience managing data managers is preferred.
*Demonstrated skills in developing CRFs and other study documentation.
*Knowledge of FDA regulations and ICH guidelines regarding GCPs.
*Team-oriented with excellent communication and interpersonal skills, demonstrated ability in
*Strong facilitation, organizational, analytical and time management skills.
*Excellent computer skills in the following programs: MS Word, PowerPoint, Excel.
*Ability to apply knowledge to new situations.
*Effective communication skills and ability to articulate complex and broad concepts and translate into
plans for action and constructive improvement.
*Ability to "roll up your sleeves" and individually contribute results to a research and development
Apply on line today at: www.ardeabio.com/careers