Job Details

  • Title: Clinical Data Manager
  • Code: RCI-08566
  • Location:
  • Posted Date: 07/24/2020
  • Duration: 5 Months
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  Job Description

Looking for someone who can objectively look at existing processes and recommend improvement that are regulation driven and work with many functions to achieve excellence through past experience while focusing on the current and future needs.

  • Has extensive knowledge and understanding of the business beyond the functional area
  • Responsible for directing the implementation of new or advanced systems, processes and tools to increase productivity
  • Is a recognized authority in clinical data management area
  • Leads data management activities for regulatory submissions
  • Drives CDM organizational strategy and implements departmental change
  • Solves complex problems directly with minimal guidance (e.g. system down-time, vendor performance issues, legacy trial rescue from acquisitions)
  • Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
  • Ensures clinical data management tasks and corresponding documentation are completed in a manner that is consistent with departmental procedures
  • Examines highly complex issues from perspectives as well as determining and applying appropriate clinical data management concepts when addressing clinical data management solutions
Qualificaitons
  • A minimum of 15 years of data management experience in the pharma / biotech industry
  • Excellent verbal and written communication skills and interpersonal skills are required
  • Capable of recommending new operating procedures as appropriate and determining if clinical data management process needs changes to improve efficiency and minimize errors
  • Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
  • Extensive knowledge FDA/EMA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is also required
  • Lead the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
  • A BS degree is required, a master’s degree is a plus
  • Oncology experience is required
  • Experience with working in a matrix environment is a must