Local Study Associate Director/Clinical Trial Manager

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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.

Kewajiban

• 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.

Kualifikasi

• 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.