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Study Data Manager II
Ref No.: 20-02572
Location: South San Francisco, California
Clinical Data Manager II
Biotech Industry!
South San Francisco, CA 94080

W2 + full medical, dental, vision Insurance!

We are still hiring during the pandemic of COVID-19 (or CoronaVirus). Your health and safety is our #1 priority at Tailored Management. We will be conducting phone/video interviews during this time to ensure your safety.

Company Overivew: An industry-leading biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases.

Position Description:
  • Acts as a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams
  • Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies
  • Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met
  • Performs the following: provides early strategic input into protocol design focused on data management issues
  • leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives
  • responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
  • responsible for the implementation of standards within Study Data Management across one or more CDM study teams
  • develops and executes ad hoc database queries utilizing data review and query tools
  • manages projects resourced externally via contract research organizations or corporate partners
Skill Requirments:
  • Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite)
  • Clinical data management system experience (EDC Medidata Rave preferred)
  • Ability to apply advanced principles, theories and concepts for CDM as a whole
  • Understanding of the conceptual basis for data management conventions, standards and processes
  • Good understanding of the role of data management, biostatistics and statistical programming in the drug development process
  • Ability to develop solutions to complex problems
  • Ability to multi-task and effectively set own priorities
  • Strong organizational skills
  • Strong communication and interpersonal skills
B.A./B.S. or equivalent with a minimum of 5 years experience in Clinical Data Management