Job Purpose

Central point of communication between Company and Investigators for clinical trial related activities to assure trials are conducted with GCP, ICH-GCP and SOP compliance, and with applicable regulatory requirement(s)

Education and Experience Requirements

Education: Bachelor degree in a scientific or health care discipline

Languages: Fluent English (oral and written)

1. Basic medical and business knowledge

2. Understands and can apply knowledge of clinical trial designs to trial execution

3. Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations

4. Expertise in communication, managing multiple priorities and computer literacy

Major Accountabilities

1.Participate / nominate new sites for clinical trials, perform evaluation of site capability and make recommendation for inclusion in clinical trial

2.Facilitate preparation and collection of site level documents

3.Execute site initiation and training activities

4.Perform monitoring visits according to monitoring plan.

5.Manage site drug supply management

6.Resolve site level update of technical systems (ClinAdmin, EDC)

7.Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc)

8.Manage recruitment implementing appropriate contingency plans as needed

9. Perform data query resolution process (both at Site and with Data Management)