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Principal Clinical Data Manager, Clinical Data Management in South San Francisco, CA



$100K - $150K*


Life Sciences


8 - 10 years

Job Description

Primary Objective of Position

Principal Clinical Data Manager, Clinical Data Management, is responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance

Major Duties/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
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Valid through: 2020-4-9

About Puma Biotechnology

Puma Biotechnology is a publicly-traded pharmaceutical company (NASDAQGS: PBYI) headquartered in Los Angeles, CA. Puma in-licenses intermediate-stage drug candidates for further development. The company was founded in 2010. The current CEO is Alan Auerbach. Currently Puma licenses three drug candidates from Pfizer: PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is an irreversible tyrosine kinase inhibitor blocking EGFR, HER1, HER2, and HER4. A new drug application was filed with the FDA for oral neratinib in July 2016. As of December 31, 2015, they had 156 full-time employees.
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* Ladders Estimates