Study Management Associate (CTMA) in Madison, NJ at Apex Life Sciences

Date Posted: 5/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Madison, NJ
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/15/2018
  • Job ID:
    849562

Job Description


Description:

  • The Study Management Associate (also known as Clinical Trial Management Associate) assists the Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. 
  • In this role the associate will perform tasks as assigned by their manager which includes but is not limited to:
    • preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. 
  • Ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

Experience:

  • Following skills required:
    • Handle and prioritize multiple tasks simultaneously
    • Work effectively in a team/matrix environment
    • Understand technical, scientific and medical information
    • Handle conflict management and resolution
    • Understand clinical study budgets
    • Plan, organize, project manage and analyze data
    • Demonstrate full competency in Microsoft Office programs. 
  • Knowledge regarding the following is also required: 
    • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
    • Knowledge of concepts of clinical research and drug development
  • Bachelor's degree preferred

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