System One Services Senior Lead Data Manager in Whippany, New Jersey

Senior Lead Data ManagerWhippany, New Jersey

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Category:Scientific & Clinical

Job ID:126409

Date Posted:03/09/2018

Title: Senior Lead Data Manager

Location: Whippany, NJ

Duration: currently approved until 12/31/18


  • Bachelor’s degree in Natural Sciences, Informatics or Medical Documentation

  • At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles.

  • At least 2 years of experience should demonstrate responsibility as a study leader.

  • Good understanding of the drug development process


  • The Sr. Lead DM assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and applies Data Management best practices

  • Incorporates and maintains company standards in clinical studies and projects for all elements of the medical standards package.

  • Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.

  • Specifies and develops study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team.

  • Prepares, tracks and implements standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.

  • Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting.

  • Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.

  • Identifies and issues queries, incorporates query replies, tracks query status.

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