Job Description


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Clinical Trial Manager

  • Ref: 298953
  • Type:
  • Location: Valhalla, NY
  • Industry: Pharmaceuticals
  • Job Level: Manager
  • Pay: Negotiable

Opportunity Description

We have an exciting new role for a Clinical Trials Manager.  Our client isn a generic drug manufacturer in Westchester County.   In this role, you will be responsible for over management of the clinical trial.  

Job Duties

  • Contribute in development  of clinical protocols, review of scientific literature, work with external consultants to develop clinical study design.
  • Studies to be completed in accordance with  investigational plan and GCP/ICH guidelines
  • Manage CRO’s and other vendors; select CROs, and maintain budgets and timelines;
  • Review and analyze clinical trial data
  • Communicate clinical information and coordinate timelines with multiple internal departments.
  • Prepare clinical documents for ANDA/NDA submissions
  • Provide support to respond to FDA deficiency letters
  • Provide clinical and FDA/ICH support with internal teams and 3rd party vendors


  • Bachelors of Science - Life Sciences related major
  • PharmD is highly desired

Experience & Skills Required

  • Good understanding of the drug development process, GMP/GLP/GCP & ICH/FDA regulations and guidelines 
  • Experience in conducting studies for Regulatory Agencies 
  • Knowledge of applicable regulations, ICH guidelines and GCP directives. 
  • 7+ years of experience in pharmaceutical industry with at least 3 years of extensive experience in biopharmaceutical aspect of drug product development. 
  • Good researching skills and expertise in searching medical literature and databases for clinical and technical information 
  • Strong Project management skills

Other Information