Clinical Project Manager

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.

Position Requirements

• 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.

The Offer
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.