Study Data Manager I

South San Francisco, CA 94080

Posted: 05/30/2018 Employment Type: Contract Industry: Drug Development - Med/Clinical Affairs Job Number: 4313

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • 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 representative
    • 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.

 

 

Skills:

  • 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.

 

Education:

  • B.A./B.S. or equivalent with a minimum of 5 years experience in Clinical Data Management
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