Lead DM (DM/ Sr. DM/ Principal DM)

Location: Somerset, New Jersey
Salary: $90,000 - $140,000

About the Opportunity

Our client is a fast-growing pharmaceutical company that is seeking a Senior/Principal Data Management to join their team. This is a great opportunity to join a team that has always embraced new technologies and partnerships to accelerate product development and generate the clinical evidence for our clients require to demonstrate real-world value.

The annual base salary range is $90,000 to $140,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.

Job Responsibilities

  • Review protocol and attend protocol review meetings or provide feedback, as needed
  • Provide feedback, as requested, during development of eCRF specifications according to the protocol
  • Assist in the design and review of study databases
  • Author or review eCRF completion guidelines
  • Develop or lead the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, data review and query handling, coding, SAE reconciliation, external data reconciliations, reports, database lock and archiving, etc.
  • Develop or lead the review of edit check specifications, as well as perform/coordinate UAT
  • Provide study metrics and status reports to internal and/or client teams
  • Provide updates to team questions on program tasks and scope
  • Perform or lead data cleaning activities
  • Perform or lead SAE reconciliation activities
  • Perform or lead external data reconciliation activities
  • Perform or lead database lock and freeze activities
  • Assist or generate study timelines
  • Ensure approved study documents are maintained and properly stored in trial master file

Job Requirements

  • Minimum of a BA/BS (life science or mathematics related preferred)
  • Minimum 4-7 years of experience of industry experience with at least 3-4 years of data management experience
  • Proficient knowledge of Medidata RAVE, Oracle InForm and/or IBM Clinical Development

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