Clinical Trial Manager
- Job Level:
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.
- 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