Study Manager (Woolcock)

Job description - Study Manager

Job code: 23122201 Job category: VSMART Job level: Manager Type of work: Full-time Duration: 1 year appointment, with possible extension Location: Hanoi or Ho Chi Minh City, may require domestic travel to research sites Regional office: Hanoi or Ho Chi Minh City Direct report: Country Director Dotted-line reporting: Clinical Trials Manager, Principal Investigator Tentative start date: January 2023

Organisation: Woolcock Institute of Medical Research

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 and Ca Mau. Currently we directly employ about 50 full-time staff and coordinates multiple study projects within lung health management and treatment across eleven provinces. We also expand research activity to other fields including antimicrobial resistance.

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

Overview: Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam: The V-SMART trial

The V-SMART Trial is a randomised controlled trial of an mHealth intervention (“Bác S? Minh” mobile application) to improve treatment outcomes for patients with multidrug resistant tuberculosis (MDR-TB). Patients and health workers are linked using new digital technologies, enabling greater continuity of care and improving patient safety and treatment outcomes. These technologies allow local health workers and TB programmes to monitor the management of adverse events, support patient adherence and respond rapidly to adverse events before they cause disabilities.

Tasks 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 conduct the study.
- Developing and evaluating study-related materials including Standard Operating Procedures, study documentation and forms, and study marketing (promotion) materials.
- Overseeing preparation and submissions of routine regulatory and ethical review applications and reports.
- Obtaining and maintaining facilities, equipment, investigational products, and licenses as required for implementing the study.
- Training field research teams and government health staff to implement various SOPs a required (such as informed consent, safety and compliance issues).
- Working closely with and notifying the Country Director and the Chief Investigators about operational issues arising in the study.
Co-ordinating and monitoring the study:
- Monitoring study progress including patient recruitment and implementation of all study procedures.
- Overseeing data collection and management.
- Monitoring data quality according to data quality plan.
- Archiving source documents.
- Managing monitoring visits and ensuring resolution of study queries.
- Preparing reports for the Country Director and the Principal Investigators on study implementation as required.
Communicating with the Country Director, the Woolcock management team, and the Principal Investigators about:
- Coordination of visits by the Chief Investigators.
- Information on key stakeholders in Australia and other countries if required.
Ensuring financial accountability:
- Implementing effective procurement control and asset management according to Woolcock policies.
- Overseeing budget, audit and financial accounting.
- Ensuring efficient use of resources.
Ensuring human resource management accountability:
- Contributing to organizational culture through encouraging an environment of continuous learning and teamwork, quality improvement and professional staff development.
Coordinating the study close-out:
- Overseeing and implementing close-out activities.
- Communicating effectively with relevant stakeholders.
- Assisting in preparation of final study report.
Overseeing completion of financial reporting.

Specific requirements:

Post-graduate degree in infectious diseases, health, public health, social sciences, health economics, or a related field. PhD preferred.
Minimum 5 years of clinical research experience.
Highly skilled in prioritization, problem solving, organization, decision-making, time management, and planning
Prior knowledge of Good Clinical Practices, Human Subject Protection, and regulatory guidelines and regulations is helpful
Detail-oriented, excellent presentation, oral, and written communication skills required
Ability to function effectively on a team, providing and receiving constructive feedback
Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues

Applications:

For interested applicants, please send a cover letter together with a CV (with the name and contact details of at least three senior referees) in English or Vietnamese and scanned copies of your related degrees, no later than 1/20/2023 by submitting the application form in the link as follows: http://bit.ly/woolcockhiring

We regret that only short-listed candidates will be contacted for interviews. Review of applications will start as soon as possible and continue until 1/20/2023, or until the post is filled, whichever is earlier

Tags: Woolcock