Head of Clinical Trials Support Group - Mahidol-Oxford Research Unit,

The Role

Responsibilities

Management:

• As a member of both the Network’s Science & Strategy Committee and the Bangkok Unit’s Management Committee, provide input into key decisions for the clinical research portfolio, activities and strategic direction of MORU.
• Lead and manage the Clinical Trials Support Group (currently more than 30 strong). Maintain and track all clinical research activities across the Network and any related research collaborations; ensure that the University of Oxford/CTSG deployed and manaitained Studyline portfolio management system is up to date. The system enables rapid reporting of all research activity of the Unit, and highlights investigators of any pending tasks, such as writing annual reports to ethics committees. Furthermore, CTSG staff assist investigators and their teams to utilize the Oxford deployed Worktribe system that is now the sole method of obtaining Ethic Approvals from the relevant ethics group, typically the Oxford Tropical Research Ethics Committee (OxTREC) for MORU Chief Investigators employed through Oxford. CTSG in conjunction with RGEA maintains MS-Power BI Dashboards that show integrated views of disparate systems that currently integrates the Studyline and WorkTribe Ethics module and this will be extended to include pre- and post-award project and finance information that Oxford plans on deploying in 2027.  

Quality and Compliance:

• Promote self-regulation of academic clinical trials by conducting research on research, implementing internal quality management system and conducting audits.
• Responsible for the creation and maintenance of CTSG SOPs; lead and facilitate the compliance to these SOPs. These SOPs and guidelines are in line with University of Oxford SOPs including those of the Centre for Tropical Medicine and the Oxford Tropical Network. Additionally, provide input to other Unit SOPs where appropriate.
• Ensure and facilitate compliance to Good Clinical Practice guidelines, other applicable local and international trial regulations, and ethical committee requirements.
• Develop cost-effective risk-based strategies to comply with the above requirements for resource-limited settings. 

Clinical Research Organisation:

• Akin to an in-house "Clinical Research Organisation", provide support in all aspects of clinical trials including traditionally outsourced components - from initial concept to study close out, regardless of geography or discipline by: 
• Coordinating finalization of research protocols, information sheets, consent forms, case report forms, standard operating procedures, data and statistical analysis plans, and other associated documents.
• Obtaining approvals from ethics committees (including the Oxford Tropical Research Ethics Committee) and local regulatory authorities. This includes submissions, resubmissions, amendments, serious adverse event reports, annual reports, and safety and closure reports. 
• Providing administrative, logistic, data management and statistical support to large clinical trials, as well as web application design and development in areas of need. 
• Together with the Clinical Trials and Research Governance team and the Global Health Network at the University of Oxford, develop best practices in quality management of clinical trials. 

Project Management:

• Support PI’s with grant applications, ensuring CTSG related costs are included in budgets and providing other supporting credentials as requested
• Actively manage the CTSG cost center and budget portfolio, in coordination with the Finance team and investigators 

Training and Capacity Building:

• Manage a training programme to provide relevant courses to researchers in collaborative sites, affiliated public hospitals and other local research institutions, including GCP, human subject protection, ethics, monitoring, statistics and data management. CTSG has developed its own courses, as existing courses produced by other organizations, are otherwise inaccessible, too expensive, not suitable for non-product registration trials or simply not available to researchers in some of the countries we work in e.g. Burma, Laos, Nepal.
• Participate in and support the public engagement and widening access activities of the Department and the University. This is anticipated to be not more than 2 days per year.
• Undertake mandatory training as required by the University, Division and Department. The specific list of training courses may change from time-to-time, in response to both legal and internal University requirements. 

Selection Criteria

Essential 

• A medical or health/science degree
• Extensive experience in the conduct and management of clinical trials including large multi-centre, multi-country clinical trials
• Experience in setting up and/or managing a clinical trials unit, either in an academic or industry setting 
• Extensive experience in managing large multinational and multi-disciplinary teams
• Experience of working in resource-poor settings e.g. Asia and Africa including facilitating compliance to international clinical trials requirements in research sites with limited experience of undertaking trials
• Experience of working in academia and industry (pharmaceutical industry or a contract research organisation)
• Experience in organising and providing training in the conduct of clinical research, including Good Clinical Practice (ICH-GCP), research ethics, data management, clinical trial regulation, coordination and governance 
• An expert in ethical requirements and international guidelines for clinical trials e.g. ICH-GCP guidelines as well as UK, EU and US FDA requirements.
• Proven ability to develop a research agenda and build a clinical research programme.
• Proven leadership and management skills

Desirable 

• A post-graduate degree in a field related to health/medical research
• Scientific publications in peer-reviewed journals

Terms & conditions

The post is based in Bangkok at the Mahidol Oxford Research unit, https://www.tropmedres.ac

The salary will be based on MORU scales and will depend on experience and qualifications.

The salary package includes:

• 13th months of salary

• health and life insurance

• social security

• provident Fund

• 20 days of annual leave

The successful applicant should have good communication skills. Interested applicants, please submit your application with detailed resumé to Chief Operating Officer

David Burton

Mahidol-Oxford Tropical Medicine Research Unit (MORU)

Faculty of Tropical Medicine, Mahidol University

420/6 Rajvithi Road, Bangkok 10400

MORU’s Commitment to Equity, Diversity, and Inclusion

MORU is committed to creating an inclusive culture and a respectful environment, and values diversity and promoting equity for all its members. MORU does not tolerate any form of harassment or victimisation and expects all members, visitors and contractors to treat each other with respect, courtesy and consideration. Successful candidates are expected to adhere to these standards and principles.