Date posted: 28 February 2019
Closing date: not noted
- Phase II & IND
- Australian & US trials management
- Full or part time
Our client is a clinical stage biotechnology company utilising their proprietary technology to reset the immune system to tolerate allergens without evoking allergic reactions. Developed over fifteen years of scientific research, they bring together world leading international expertise that is enabling progression of their exciting new immunotherapy.
Due to their recently announced pivotal success in their Phase I trial, they are seeking a new Clinical Project Manager to join their team. Reporting to the CEO, your role will be responsible for managing the Phase II trials, under an IND, across Australia and the US. You will ensure all deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role.
- Support the CRO & develop and maintain strong, collaborative relationships with key stakeholders internally & externally.
- Day to day management of the clinical trials to ensure deliverables are met in all phases of the trial.
- Coordinate clinical trials supply with relevant CTU’s & monitoring and auditing of manufacture of product for clinicaltrial supply.
- Liaison with ethics committees and regulatory authorities.
- Drafting site materials including training, manuals and support documentation.
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
- Review of clinical monitoring reports to ensure timely completion and identification of issues.
- Maintain trial metrics.
- Ensure trial is conducted in accordance ICH/GCP and all regulatory standards.
- At least 5 five years of trial coordination experience in a clinical research environment in biotechnology, pharmaceutical, devices or CRO environments.
- Minimum Bachelor’s in a science-based area, e.g. immunotherapy, immunology, vaccine development, drug development
- Strong project management & organisational skills in overseeing clinical trials and ensuring that all aspects & documentation are attended to with a high level of attention to detail.
- Relevant therapeutic experience in a global setting with a solid understanding of drug development.
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Strong client facing/client relationship management experience.
- Ability to work hard under pressure and face challenges.
- Budget management/financial project tracking experience.
- Excellent interpersonal and communication skills with the capacity to communicate with individuals across disciplinesand 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 vaccine/immunological product is highly desirable.
- Understanding of US trial requirements essential.
- Experience with conduct of Phase II & Phase III 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. Willingness to travel is required for this role. 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 email@example.com