Local Study Associate Director, SMM TH Oncology

To lead Local Study Team(s) at the 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. The Therapeutics area responsible is the Oncology department.

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.

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.