Clinical Data Manager Lead

4 weeks ago


Cambridge, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Clinical Data Manager

At Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Clinical Data Manager to lead our clinical data management activities. The successful candidate will be responsible for overseeing the creation and approval of DM study documentation, reviewing clinical data and metrics, and coordinating cross-functional data review meetings.

Key Responsibilities:
  • Lead all clinical data management activities for assigned clinical studies, ensuring timely and high-quality delivery.
  • Oversee the creation and approval of DM study documentation, including CRFs, completion guidelines, and database specs.
  • Review clinical data and metrics to identify data quality trends, compliance with the protocol, and potential risks to timelines.
  • Coordinate cross-functional data review meetings with the clinical team and manage the collection of data issues.
  • Produce regular data listings for the clinical team and other functional areas.
Requirements:
  • 5+ years of clinical data management experience in the pharmaceutical industry, with a BS degree.
  • Experience leading all DM functions for clinical studies, including global studies.
  • Expertise with Medidata RAVE and other databases, such as IVRS/IWRS and Central Imaging.
  • Knowledge of SDTM & CDISC.
  • Ability to work hands-on to support in-house DM work as required.

We offer a dynamic and challenging work environment, with opportunities for growth and development. If you are a motivated and experienced Clinical Data Manager, we encourage you to apply for this exciting opportunity.



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