About the role
Our client is seeking a Clinical Project Manager to join their newly expanding Australian team. Your key remit will be to manage the early phase clinical trials for their exciting new technology.
- Oversight of all pre-study, on-study and study close out activities
- Preparation of sponsor based clinical trial documentation including protocols, investigator’s brochures, ethics submissions, and patient information and informed consent documentation.
- Assist in preparation of project plans and budgets.
- Assist in the selection and subsequent liaison with CROs and investigators.
- Coordinate clinical trials supply with relevant CTU’s, including preparation of relevant documentation, monitoring and auditing of manufacture of product for clinical trial supply.
- Liaison with ethics committees and regulatory authorities.
- Ensuring studies are conducted in accordance with study protocols, ICH-GCP guidelines and local and international regulatory guidelines.
- Establish operational processes/process improvement for management of clinical programs.
- Ensure key milestones and project timelines are met.
- Tertiary qualifications in biomedical sciences, nursing or a relevant area of clinical trials/research.
- Minimum of 3-5 years relevant clinical trial project management or clinical research experience in the biotechnology, pharmaceutical, devices, hospital or CRO environments.
- Excellent understanding of GCP work practices and processes.
- Strong project management & organisational skills in overseeing trials and ensuring that all aspects & documentation are attended to with a high level of attention to detail.
- Excellent interpersonal and communication skills with the capacity to communicate with individuals across disciplines and at all levels in the organisation.
- Demonstrated ability to work both independently and harmoniously as part of a small agile multidisciplinary team.
- Experience with conduct of clinical studies with a biological product is preferred
- Understanding of Australian and international trial requirements.
- Experience with conduct of Phase I and Phase II studies. Additional trials an advantage.
Our client has just landed in Australia and you will be part of a new and exciting venture. Well-funded through to the end of Phase I they offer an exceptional opportunity. Successful candidates will attract a competitive salary package. As a valued member of this new and expanding team, you will have the opportunity to demonstrate your talent and shape this emerging business.
About the organisation
Our Client seeks change markers who are committed to developing immunotherapy solutions that improve patient outcomes. Their innovative proprietary immunotherapy platform circumvents current drawbacks in current cancer treatment.
How to apply
If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on +61 437 332 272 for a confidential discussion and/or email your résumé with your cover letter: firstname.lastname@example.org
Candidates that are successful for interview will be contacted within 2 weeks of applying. All candidates will be notified on receipt of their application. If you have not had a reply within 2 weeks, we would welcome an email and we WILL respond.
Roles may be preferably based in Victoria however other states will be seriously considered.
Please quote in application: Clinical Project Manager via Pro Bono Australia.