[Remote] Principal Clinical Data Manager - Remote Position

Note: The job is a remote job and is open to candidates in USA. Puma Biotechnology Inc. is a company focused on developing innovative therapies for cancer treatment, and they are seeking a Principal Clinical Data Manager to lead study data management activities. The role involves coordinating data management processes with CROs, ensuring quality control, and supervising data management deliverables to achieve database lock.

Responsibilities
• Reviews listings to identify data discrepancies and tracks resolutions
• Works with Study team to design mock CRFs based on the protocol
• Leads database design, implementation and testing activities
• Supervises all data management deliverables and associated timelines with the CRO to ensure a quality database lock
• Coordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

Skills
• Bachelor's Degree in a biological sciences or other medically related areas
• Minimum of 7 years of biometrics/data management or related experience in the biotechnology/pharmaceutical industry
• Familiarity with data management software (e.g. Medidata, Oracle Clinical)
• Working knowledge of coding dictionaries – MedDRA and WHODRUG
• Knowledge of Oncology clinical trials
• Nursing background
• Vendor management experience
• Familiarity with SAS
• Knowledge of Excel, Python, or R is helpful

Benefits
• Annual bonus target
• Robust benefits package

Company Overview
• At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care. It was founded in 2010, and is headquartered in Los Angeles, California, USA, with a workforce of 201-500 employees. Its website is http://www.pumabiotechnology.com.

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