Quản lý thử nghiệm lâm sàng (Trial Manager)

Mô tả Công việc
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