Senior Trial Manager

Classification: ANU Officer 8 (Research)
Salary package: $109,945 - $117,567 per annum plus 17% superannuation
Term: Full-time, Fixed Term (up to 2 years)
Full-time role
Flexible, friendly, and supportive team environment
Make a leading contribution
Remuneration and benefits packages including 17% superannuation contributions; Christmas to New Year leave in addition to annual leave; salary sacrificing options for cars, parking, childcare and more
Our academic and research staff in the ANU College of Health and Medicine (CHM) are committed to solving problems through big picture and applied scientific research, and improving health outcomes for people around the world. These inspiring ambitions are realised through our 3 Schools - the John Curtin School of Medical Research; the National Centre for Epidemiology and Population Health; and, the School of Medicine, Psychology and Health Leadership – who work together to deliver world-class research and education across the spectrum of medicine and health-related fields, and partnership with the health sector at the local, national and international levels. The Clinical Hub for Interventional Research (CHOIR) contributes to the College of Health and Medicine’s Strategic Plan (TRANSFORM) by strengthening its commitment to translational research.
About the Role
You will be responsible for the development, implementation, coordination, management, and monitoring of clinical trials within CHOIR. You will use your experience in research to devise, implement, monitor, and report on the conduct of research projects from inception, and provide guidance on operational matters. You will also provide input into the development of suitable research networks to support conduct of trials in haematological malignancies, including site selection and ongoing evaluation.
Responsibilities include, but are not limited to:
Participation in assessment, start-up, and close-out of clinical trial sites
Operational input during development of clinical trials
Preparation and management of documentation and materials required for trial conduct
Preparation and management of ethics and regulatory applications
Lead relevant project specific meetings and oversee project administration
Provide guidance and oversight regarding operational conduct of clinical trials and their academic aspects
Provide timely and focused reports to all stakeholders regarding trial implementation and progress
Oversee the production of clinical study reports, in collaboration with data managers and study statisticians, and assist academic staff in the preparation of abstracts and manuscripts for scientific meetings and for publication
Onsite and remote study site monitoring, including report management
Management of serious adverse event reports and safety information
Budget and site contract development, general management of trial finances
Manage relationships with key stakeholders, including representatives from trial sites, industry, academic, and clinical partners
Ensure all trials are managed and monitored according to the National Statement on Ethical Conduct in Human Research and ICH-GCP requirements
Participate in team meetings and special projects to develop and improve processes and systems
The role of Senior Trial Manager reports to the CHOIR Program Head through the CHOIR Program Manager. This role has no direct reports. This role is based in the ACT.
About You
Our ideal candidate will be a highly motivated and experienced individual who has a strong interest in health research, and who is keen to play a key role in delivering high quality clinical trials.
To be successful in the role, it is essential that you demonstrate:
Postgraduate qualifications in a public health or biomedical discipline, or progress towards postgraduate qualifications and extensive relevant experience in the conduct of medical research (> 5 years).
Experience in the successful coordination of clinical trials in haematological cancers or a closely related field at a national level
Proven experience planning and coordinating multi-centre clinical trials including monitoring, central laboratory specimen collection, shipment and storage, drug distribution and accountability processes.
Experience in the development of analysis plans and clinical trials analysis as well as preparation of publications, reports and conference presentations
Proven ability to work effectively both independently and as part of a multidisciplinary team, including clinical and laboratory stakeholders
Excellent computer skills including experience and competence in using data collection instruments and programs
Excellent organisational skills and ability to prioritise own workload and work independently as well as effective member of a team
High level understanding of equal opportunity principles and a commitment to the application of EO policies in a university context
If you have a passion for health research and working in a collaborative team environment we would welcome an application from you.
For further information, please contact Sarah Davidson: **************@anu.edu.au
ANU values diversity and inclusion and is committed to providing equal employment opportunities to those of all backgrounds and identities. For more information about staff equity at ANU, visit https://services.anu.edu.au/human-resources/respect-inclusion
Application information
In order to apply for this role please make sure that you upload the following documents:
A statement addressing the selection criteria.
A current curriculum vitae (CV) which includes the names and contact details of at least three referees (preferably including a current or previous supervisor). If your CV does not include referees you can complete these online when prompted in the application form.
Other documents, if required.
Applications which do not address the selection criteria may not be considered for the position.
Please note: The successful candidate must have rights to live and work in this country and will be required to undergo a background check during the recruitment process. An offer of employment is conditional on satisfactory results.