Clinical Data Manager

Manpower Engineering

Job Description

Job Responsibilities:

  • Demonstrated subject matter expertise in all aspects of the Data Management discipline. Ability to support multiple studies concurrently with minimal oversight by function manger.
  • Advocates the DM position within study team meetings and coaches vendor staff supporting DM work.
  • May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eCOA, data visualization, etc.
  • May contribute to subject matter expertise to support process improvement initiatives.
  • Oversees multiple DM vendors and provides training as necessary
  • Participates in study level budget review activities for individual studies
  • Provides feedback and suggestions for improvement in DM vendor discussions.
  • Uses metrics and key performance indicators to monitor vendor performance.
  • Performs vendor oversight activities across multiple studies. Proactively shares and provides suggestions on how to improve vendor oversight with functional manager.
  • Documents any process related deviations and communicates to functional manager.
  • May attend or participate in key industry conferences or related initiatives.
  • Strong cross-functional understanding on the impact of data management processes to other stakeholders.
  • Has a good understanding of regulatory guidelines and issues (i.e. ICH GCP), and understands the connection to DM deliverables.
  • Develops a strong partnership with vendor lead data managers to ensure program level deliverables are on track.
  • Leads the data review meetings with Medical, Clinical, Biostats,and Programming in support of key reporting events or database lock plans.

Job Requirements

 

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