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Study Management Associate

Irvine, CARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/301287
 

Study Management Associate

 

Job Summary

The Study Management Associate (also known as Clinical Trial Management Associate) assists the Sr. Clinical Trial Management Associate, Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. 

Job Responsibilities

  • 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 all of the client's departments
  • Supporting the monitoring team and study sites with relevant study information
  • Supporting clinical operations. 
  • The incumbent 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 of the client's policies and procedures. 

Education & Qualifications 

  • 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, and 
  • Demonstrate full competency in Microsoft Office programs. 
  • 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

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/301287