Manager, Data Management

Organization: 
Ardea Biosciences/Astra Zeneca
Job Location: 
San Diego, CA
Job Description: 

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
Responsibilities include:
• 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.

Requirements: 

• 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 managing indirectly.
• 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 effort.
Interested parties please apply today at: www.ardeabio.com/careers

Contact Information: 

Interested parties please apply today at: www.ardeabio.com/careers

About Our Organization: 

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.