BASIC QUALIFICATIONS · Bachelor's degree in Life Sciences, Computer Science, or equivalent · Minimum of 5 years of relevant project management experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions · Strong project management, communication (written and oral), decision-making, influencing, and negotiation skills · Familiarity with Electronic Data Capture systems, Clinical Data Management Systems/relational databases (e.g. Oracle InForm and Data Management Workbench, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire, J-Review) · Experience with MSProject or other enterprise project management tools PREFERRED QUALIFICATIONS · Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.) · Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable · Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)