Major responsibilities:

• Overall responsibility for project delivery in terms of commitment, budget, and time within the country

• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary. Proactively identify and resolve study problems and issues.

• Lead and optimize the performance of the local Study Team(s) at the country level ensuring compliance with AZ SOPs, ICH-GCP and local regulations

• Selection of potential Investigators considering the capability, competence, etc., of the Hospitals/sites.

• Ensure timely start-up of project from EC/IRB and Thai FDA submission to site initiation

• Perform co-monitoring & QC visits with study monitor(s)

• Organize regular Local Study Team meetings on an agenda-driven basis

• Ensure completeness of the Trial Master File

• Ensure accurate payments related to the study are performed.

• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural Documents.

• Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Study Master File.

• Plan and lead activities associated with audits and regulatory inspections in liaison with the Clinical Process Manager and QA.

• Prepare and maintain the study budget at the country level

• Provide regular information to Line Managers at the country level on studies and planned study milestones/key issues.

Minimum Requirements and Preferred Background:

• Minimum University degree, preferred in Pharmacy or healthcare-related field.

• Minimum 5 years' experience in Clinical Operations

• Excellent knowledge of spoken and written Thai and English.

• Good ability to learn and to adapt to work with IT systems.

• Good project management, decision-making, coaching, interpersonal, and negotiation skills.

• Excellent communication skills, verbal and written, and presentation skills.