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Title:Associate Director, Data Management
Salary:Open
Experience:10+
Location:NJ - Northern

Description:
Manage data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics. Define and implement data standards across compounds.

Responsibilities:
  • Collaborate with Biostatistics and Clinical Operations on standardization of database design, edit checks, data review and data extracts.
  • Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions
  • Review data definition files and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements
  • Review CRF for consistency with Company standards
  • Collaborate on standardization efforts for data management and biostatistics
  • Support development and implementation of EDC systems
  • Define data integration standards and support pooling of databases for production of integrated summary of safety
  • Define global department strategy and standard operating procedures

Requirements:
  • B.S. required, MS prefered. Preference in science or computers
  • Ten (10) years experience in clinical trials in a data management role
  • Excellent communication and writing skills
  • Experience with cancer clinical trials preferred
  • Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management required
  • Knowledge of EDC and CDISC required

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