Information Technology Executive

To work closely with team at Investigational Site(s), provide them with necessary support, coordinate activities, implement best practices in order to ensure high quality data in Clinical Trials in accordance to Good Clinical Practice, regulatory requirements and company Standard Operating Procedures. 

Responsibilities

• Coordinate/perform work at Site(s) in accordance with ICH GCP guidelines, applicable local regulatory and EC requirements, the contractual requirements and the approved study protocol and other study related documents 
• Collect Essential Documents including Investigational Product (IP) release documents for assigned site(s) in line with applicable regulations and study specific client SOPs and/or requirements 
• Responsible for maintenance of Investigator Site File, Pharmacy File, and other site/study specific documents at assigned site(s) 
• Support pre-identification of patients and planning of screening and enrolment activities in consultation with investigators.
• Coordinate various site visits i.e. pre-study, site initiation, interim monitoring visits and close-out visits. Ensure site readiness for these visits 
• Coordinate and prepare site for sponsor visits, QA or regulatory authority visits

Qualifications

Any Life Science Graduate