Local Study Associate Director for BioPharma Department
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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.
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.
Date Posted
12-ม.ค.-2026Closing Date
30-เม.ย.-2026AstraZeneca 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 authorization and employment eligibility verification requirements.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
