Senior Data Manager - FS

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
  

What You'll Be Doing

• Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
• Provide input to and review of Data Management Plans in support of clinical study deliverables
• Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process
• Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly
• Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required
• Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements
• Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required
• Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.
  

What We Are Searching For

• Bachelor's degree or international equivalent, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience
• 3 years of practical experience with database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, etc).
• Proven experience with study start up activities/ phase.
• Good Communication