Science, Pharmaceutical & Food

Clinical Study Manager

  • Full Time
  • United States
  • 41888622

Clinical Study Manager – Gene and Cell Therapy

My client an innovative biotechnology company who focus on cell and gene therapy have an exciting opening for a Clinical Study Manager to join their highly motivated team.

Responsibilities:
Lead the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight for the assigned study. Responsible for managing clinical trials from start to completion, designing study protocols, arranging site visits, writing case and clinical reports. Accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. Accountable for the study timelines, study budget.

Experience:

Bachelor’s degree in science or other Medical related field
5 years of clinical affairs experience in the pharma or biotech sectors
Knowledge of ICH/GCP and FDA regulations
Experience leading clinical study
Experience in Infectious Diseases would be an advantage
Cell and Gene Therapy experience would be an advantage

Salary + Benefits

DOE:  $90,000.00 – $95,000.00 PA 
401(k), Dental, Disability, Health, Life, Stock Options + Bonus