Date Posted – 21 May 2021
Part time or full time · Biotech · Oversight role
Our client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms. Now is an exciting time as they progress to pivotal trials of their technology.
Your key remit will be to have responsibility managing the early phase clinical trials for the company. The position will be responsible for successful preparation of study documentation, execution of all clinical trial programs for early-stage clinical assets within the company, review data and results according to local regulatory requirements, policies and guidelines in line with ICH GCP. The role is responsible for interacting with clinical and research staff, reviewing trial progress, and reporting to timelines and budgets.
- 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, liaison with ethics committees and regulatory authorities, monitoring and auditing of manufacture of product for clinical trial supply.
- 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.
- Project manage clinical operations of clinical studies.
- Develop strategies for efficient patient recruitment and drive recruitment.
- Ensure key milestones and project timelines are met.
- Minimum of 3-5 years relevant clinical trial or clinical research experience in the biotechnology, pharmaceutical, hospital or CRO environments.
- Experience with HREC review and approval processes
- Experience with IND or NDA submissions would be well regarded.
- Excellent understanding of GCP work practices and processes.
- Knowledge of and experience with clinical trial project management in a pharma/biotech/devices setting.
- Experience with conduct of clinical studies with an ocular product.
- Understanding of US trial requirements.
- Experience with conduct of Phase I and Phase II studies.
- Passion, or the willingness to become immersed in work.
- Outcome-focussed and demonstrated initiative in past roles.
- Self–starter with ability to set own priorities.
- Strong organisational skills and time management skills.
- Strong project management skills with strong attention to detail.
- Excellent interpersonal and communication skills.
- Demonstrated ability to work both independently and as part of a multidisciplinary team.
- A capacity to communicate with individuals across disciplines and at all levels in the organisation.
- Willingness to travel interstate or overseas if required. Overseas travel likely to be no more than 2 trips per year. Interstate travel likely to be no more frequent than monthly.
As a valued member of this team, you will have the opportunity to demonstrate your talent and support to shape this new and exciting opportunity. You must reside in and hold full working rights in Australia.
To join our client in this exciting opportunity please email your cover letter & CV to email@example.com. Confidential enquiries to Marilyn Jones on +61 40 100 3553.