- Responsible for all the clinical operations
- Coordinate the activities associated with the evaluation, initiation and management of clinical
- Coordinate clinical and regulatory activities with company regulatory advisor.
- Overview all clinical personnel.
- Lead in the selection and implementation of clinical
- Contribute to the preparation and development of clinical protocols
- Support the preparation and submission of regulatory reports and clinical study reports with regulatory advisor.
- Provide technical, scientific, and administrative assistance to the
- Manage vendors and communicate with sites and others within the company in case of escalation (primary contact-CRA), both in and outside the
- Coordinate the organisation of investigator
- Assist in the design and format of CRFs, study guides and subject's
- Track third party vendor activities and contribute to local budget
- Oversee monitoring of clinical sites during study
- Ensure budgets, schedules, and performance requirements are
- Monitor progress of studies identifying delays and initiation of corrective actions when