Quality Assurance Manager
Mahidol-Oxford Research Unit,
The Clinical Trials Support Group (CTSG) is a group that supports researchers by assisting with protocol development, ethics applications, quality monitoring, training, data management, statistical analyses and other administrative support.
The Bangkok unit is responsible for all aspects of the conduct of clinical trials, including the complex logistical challenges of resourcing the trial sites located across South East Asia and Africa. Trials are currently being conducted in Thailand, Vietnam, Cambodia, Laos, Myanmar, Democratic Republic of Congo, India, Bangladesh, Ethiopia and Afghanistan. The post of the Clinical Trials Administrative Coordinator is pivotal to the Tropical Medicine Clinical Trials Programme, ensuring that we source and deliver all necessary supplies, complying with any country specific regulations, throughout the lifecycle of the trial.
This position is located within the Mahidol Oxford Tropical Medicine Research Unit (MORU) Clinical Trials Support Group (CTSG) - Bangkok. This is a new post and will report to the Head of CTSG. The primary role of the post holder will to develop, implement and maintain quality systems, policies and lead a review of Standard Operating Procedures (SOPs) to identify any deficits, facilitating any necessary changes.
- Lead the development, implementation and maintenance of a Quality Management System for the CTSG’s activities.
- Ensure the CTSG is compliant with national and international standards for the conduct of clinical research.
- Provide expert advice on trial regulations governing the conduct of the clinical trials programme.
- Oversight of the CTSG’s SOPs, including the review and audit of working and management practice to ensure that the SOPs accurately reflect processes and is followed by staff across MORU’s units.
- Ensure that the SOPs are in place for all CTSG conducted trial procedures and coordinate regular review in accordance with the CTSG review policy.
- Review the current processes for the development, review, updating, and implementation of SOPs and make recommendations for any necessary improvements.
- Take responsibility to ensure all staff read and follow the SOPs that govern their tasks.
- Participate in the risk assessment of new protocols and support the development of monitoring/audit plans.
- Participate in protocol development and review including drafting of a template QA section for use in protocols.
- Implement and conduct internal audits.
- Take the lead in preparing for any regulatory inspections, coordinate the preparation of the response and monitor follow up to ensure any corrective actions are completed within the designated timeframe.
- Liaise with sister programmes including Oxford University Clinical Research Unit, Vietnam to share learning and collaborate on the development of QA processes across both units.
- Work closely with MORU’s Quality Assurance Team to ensure alignment with programme wide systems and share learning.
- Develop Corrective and Preventative Action plans as necessary.
- Bachelor’s degree or equivalent qualification
- Substantial experience of working in a Quality Assurance role and in the conduct of clinical trials
- Experience in writing SOPs
- Excellent interpersonal and communication skills
- Good command of written and spoken English
- Skilled with Microsoft Office especially Word and Excel
- Expertise in using electronic database management systems to display, control and review documents.
- Competence in audit
- Good time management and ability to multi-task
- Systematic thinking, analytical and management skills
- Comprehensive knowledge of national and international standards for the conduct of clinical research
- Experience with an academic research organization will be an advantage
Interested applicants, please submit your application with detailed resumé and recent photo to
Dr Zoe Doran
(click Apply Now)
Mahidol-Oxford Tropical Medicine Research Unit (MORU)
Faculty of Tropical Medicine, Mahidol University
420/6 Rajvithi Road, Bangkok 10400
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Mahidol-Oxford Research Unit,
Mahidol-Oxford Tropical Medicine Research Unit (MORU) is a medical research collaboration between the Faculty of Tropical Medicine, Mahidol University, the University of Oxford, and the Wellcome Trust (UK). Our main research interests are the epidemiology, diagnosis, pathophysiology and treatment of malaria, scrub typhus, melioidosis, leptospirosis and other tropical infections which impose a substantial disease burden on rural populations throughout this populous region. MORU is looking for enthusiastic people to join our team.