System One Services Senior Lead Data Manager in Whippany, New Jersey
Senior Lead Data ManagerWhippany, New Jersey
Apply with System One
Category:Scientific & Clinical
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.
Apply with System One