Senior Clinical Data Manager - Contractor - Remote

Functional Services United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Senior Clinical Data Manager to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

Responsibilities: 
  • 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.
  • Mentor and train Data Managers
  • Performs additional duties as assigned
  • Ability to perform overnight business travel, up to 10%