Director / Sr. Director, Clinical Operations - Klein Hersh International : Job Details

Our client is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options.

The Director/Sr. Director - Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with the company's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program are in compliance with the company's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Sr./Director - Clinical Operations is also responsible for the development and implementation of clinical monitoring standards and best practices for effective clinical monitoring of investigational sites in accordance with regulations for identifying and leading strategic and continuous improvement initiatives in monitoring and clinical project management.