Job Description

Apply

Submit Email

If you've inquired to HumanEdge in the past, please use the same email to help shorten the inquiry process. If you've never inquired or don't remember, you may use any valid email address.

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

Education

  • 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

#ZR3

INDWP