Date posted: 27 February 2019
Closing date: not noted
- Part time or full time
- Exciting new role
- Phase II Project Management
Our client is developing a world leading platform technology to deliver drugs to specific sites in the body. Their exciting technology enables control over delivery rate ensuring accurate & therapeutic drug dosage. The company has secured a world-class team of more than 20 staff that provide the core chemistry and development capabilities. Leveraging relationships with key world leading providers across Australia and the world, they are harnessing capabilities in pharmaceutical chemistry, polymer chemistry, ophthalmology and medical research.
Due to their continued success in early stage trials, they are now seeking a new Clinical Project Manager to join their team. Reporting to the Head of Commercial Operations, your role primarily will be responsible for assisting in the management of the early phase clinical trials for the company.
- 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.
- 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 an ocular product is highly desirable.
- Understanding of US trial requirements.
- Experience with conduct of Phase I and Phase II studies.
Our client offers an exceptionally collegiate and supportive work environment. They expect, and provide, excellent professional standards and work ethics with a ‘hands on’ attitude. Successful candidates will attract a competitive salary package. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this emerging business.
If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 0437 332 272 for a confidential discussion and/or email your résumé with your cover letter to firstname.lastname@example.org