Local Study Associate Director

To lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed targets, budget and timelines complying with AZ SOPs, ICH-GCP as well as relevant local regulations.

Therapeutics area responsible is Biopharmaceutical department.

Major responsibilities:

• Overall responsibility for project delivery in term of commitment, budget and time within the country
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary. Proactively identify and resolution of study problems and issues.
• Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with AZ SOPs, ICH-GCP and local regulations
• Selection of potential Investigators considering 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 local part of the Study Master File.
• Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
• Prepare and maintain study budget at country level
• Provide regular information to Line Managers at 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, negotiation skills.
• Excellent communication skills, verbal and written and presentation skills.