Quản lý thử nghiệm lâm sàng (Trial Manager)

Job Description

Job Description:

As Trial Manager, the incumbent is responsible for coordinating the implementation of clinical trials. This role will take a lead role in planning, executing, monitoring and closing the trial, as well as overseeing quality assurance and safety in keeping with international standards of Good Clinical Practice (GCP). The Trial Manager is responsible for building a team of enthusiastic and capable research staff.

Duties and Responsibilities:

• Develop and strengthen key relationships with government partners;
• Planning and executing the trial
  • Prepare protocol and trial documents for registration according to requirements of sponsors and authorities
  • Developing and implementing pilot projects to test key components of the trial
  • Development and evaluation of trial-related materials including the Standard Operating Procedures, trial documentation and forms, and trial marketing (promotion) materials
  • Obtaining and maintaining facilities, equipment and licences as required for implementing the trial (including drug procurement)
  • Training field research teams and government health staff to implement the SOPs (including informed consent, safety and compliance issues)
  • Develop and update project log frame regularly.
• Co-ordination and monitoring of the clinical trial
  • Oversee patient recruitment
  • Monitoring of the implementation of the trial including subject recruitment and implementation of all study procedures
  • Reviewing study protocols, progress reports, and interim results to ensure that studies are being conducted according to design and that results are accurately recorded
  • Coordinating with investigators to ensure that all research activities are carried out in accordance with protocols and approved by ethics boards
  • Ensuring timely and accurate data collection and completion of case report forms relevant to clinical trials or research projects, and maintain the Trial Master File (TMF) to GCP standards
  • Registration and management of adverse events
  • Managing monitoring visits and dealing with queries
  • Arrange meetings, teleconferences and video conferences relating to the project
• Preparing and sending correspondence to investigators and sponsors regarding study procedures and requirements
• Financial accountability
  • Preparing budgets and managing budgets for clinical trials
  • 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 trial
  • Trial closure
  • Communication with organisations involved.
  • Assisting in preparation of the final study report
  • Oversee completion of financial reporting.
• Notifying Head of Clinical Trials and Chief Investigators about problems arising in the study

Key Relationships:

• Direct report: Head of Clinical Trials of the University of Sydney Vietnam Institute
• Dotted line reporting: Principal Investigator
• Supervisor for: Key staff working with the project
  • Project Officers
  • Data Manager
  • Local financial controller
  • Senior field staff
  • Technical managers (such as Laboratory staff)

Contract Duration: One (01) year appointment with possibility to extension based on performance