In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Requirements:
– University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
– University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
Experience
– Good organizational and time management skills
– Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
– Interact with internal and external customers with high degree of professionalism and discretion
– Good computer skills with good working knowledge of a range of computer packages
– Ability to lead and develop junior staff
– Fluent English and Hebrew
This position is open to all candidates.
