Associate Director - Clinical Data Management
November 26
🇺🇸 United States – Remote
💵 $142.5k - $237.5k / year
⏰ Full Time
🟠 Senior
👔 Director
🦅 H1B Visa Sponsor
Description
• An Associate Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. • The Associate Director DM will provide oversight to ensure end-to-end data management consistency across the portfolio. • Contributes to and implements the strategic direction of the Clinical Data Management functional area. • Contributes to the overall strategy, unified objectives and areas for development of Clinical Operations.
Requirements
• Bachelor's degree in science or related area (or equivalent) • 10+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management. • Experience within all phases of clinical trials. • Experience with clinical trials and the drug development process • Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy • Experience with CDISC (SDTM); as well as data collection requirements in clinical trial • Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials • Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices • Experience working on early and late-stage submissions as per local/regulatory requirements • Experience working in and leading cross-functional teams
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