Clinical Trial Manager (The Woolcock Institute of Medical Research)

• Job code: 20102302
• Job category: Clinical Trials Regional office: HCMC
• Job level: Manager
• Type of work: Fulltime
• Duration: 12 months with possibility of extension
• Location: Ho Chi Minh City, may require domestic travel to research sites
• Direct report: Head of Clinical Trials
• Dotted-line reporting: Executive Director, Chief Investigator
• Tentative start date: As soon as in November 2023

About the organization

The Woolcock Institute of Medical Research is affiliated with the University of Sydney in Australia and is recognized as one of the leading research institutions for respiratory diseases and sleep disorders. Operating in Vietnam since 2009, we have undertaken large operational, epidemiological, and clinical research projects and run training in epidemiological and operational research methods for Vietnamese doctors and public health workers. The Woolcock Institute has three research centres and offices in Ha Noi, Ho Chi Minh City and Ca Mau.

For more information about us, please visit:

• Woolcock Institute of Medical Research in Sydney, Australia: www.woolcock.org.au
• Woolcock Institute of Medical Research in Vietnam: www.woolcockvietnam.org

• Taking a leading role in planning, executing, monitoring, and controlling the study
• Overseeing quality assurance and safety for the study, in keeping with international standards of Good Clinical Practice
• Building a team of enthusiastic and capable research staff in study sites

Duties and Responsibilities:

• Develop and strengthen key relationships with government partners.
• Planning and executing the study:
  • Developing and implementing pilot projects to test key components of the study;
  • Assembling and training a team to oversee the study;
  • Development and evaluation of study-related materials including the Standard Operating Procedures, study documentation and forms, and study marketing (promotion) materials;
  • Overseeing preparation and submission of routine regulatory and ethical review submissions and reports;
  • Obtaining and maintaining facilities, equipment, investigational products, and licences as required for implementing the study;
  • Training field research teams and government health staff to implement the SOPs (including informed consent, safety and compliance issues);
  • Develop and update project GANTT chart regularly.
• Co-ordination and monitoring of the study:
  • Monitoring of the implementation of the study including subject recruitment and implementation of all study procedures;
  • Data collection and management;
  • Monitoring data quality;
  • Collection and archiving of source documents;
  • Registration and management of adverse events;
  • Managing monitoring visits and dealing with queries;
  • Preparing reports for the Country Director and the Principal Investigators on progress of study implementation;
  • Communication with the Country Director, the Woolcock management team, and the Chief Investigators;
  • Coordination of visits by Chief Investigators;
  • Managing communication with key stakeholders in Australia and other countries if required;
  • Prepare project progress reports,
• Financial accountability:
  • Establish effective procurement control and asset management;
  • Oversight of budget, audit and financial accounting;
  • Ensure efficient expenditure of resources;
  • Ensuring appropriate financial control processes are followed.
• Human resource management accountability:
  • Recruit local staff to conduct the research;
  • Supervise performance of all staff ;
  • Foster a community of learning and teamwork, continuous quality improvement and continuous professional development for staff.
• Close-out of the study:
  • Study closure;
  • Communication with organisations involved;
  • Assisting in preparation of the final study report;
  • Oversee completion of financial reporting.
• Working closely with and notifying Country Director and Chief Investigators about problems arising in the study.

Key attributes:

• Required formal qualification in study management, clinical study management, international development or a field of study related to the scope of position;
• Ability to work within a team and organise it;
• Management skills;
• Strategic planning;
• Ability to prioritise;
• A motivator with good listening skills;
• Focused, but flexible approach;
• Willingness to work hard;
• Knowledge/experience of all relevant guidance/regulations;
• Ability to pay close attention to detail;
• Excellent team leadership skills;
• Strong organizational management skills;
• Experience working in a cross-cultural context and in developing country setting (preferably Vietnam, but this is not essential);
• Skills in institutional capacity-building;
• Experience in engaging with government and non-government partners;
• Proven experience in negotiation and managing conflict;
• Fluency in English and excellent communication skills;
• Ability to communicate in Vietnamese.

Applications:

We regret that only short-listed candidates will be contacted for interviews. Review of applications will start as soon as possible and continue until 30/11/2023, or until the post is filled, whichever is earlier.