Study Data Manager

Job Title: Study Data Manager

  • 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.

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

Why Kelly®?

With Kelly, you’ll have direct connections to leading IT organizations in the best companies around the globe—offering you the chance to work on some of today’s most intriguing, innovative and high-visibility projects. In a field where change is the only constant, our connections and opportunities will help you take your career exactly where you want to go. We work with 90 of the Fortune 100™ companies companies and found opportunities for more than 8,600 IT professionals last year. Let us help advance your career today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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