Clinical Project Specialist
- Experience Level
- Experienced (non-manager)
- Pivotal Trials
- ASX listed
Our client is an is an ASX listed clinical stage biotechnology company focused on developing new therapeutic treatments identified using its proprietary drug discovery platform. Now is an exciting time to be joining our client as they undergo further expansion and progress to pivotal trials.
Reporting to the Clinical Program Manager, your focus will be to support and facilitate the planning and execution of sponsored and investigator initiated clinical studies, including a global pivotal study. Your proficiency in the commercial aspects of drug development, combined with your knowledge in the many complexities of clinical trials, will ensure yours and our client's success.
- Operational oversight of the clinical studies to ensure key milestones, project timelines & deliverables are met during study start-up, delivery and close out.
- Support in the management of CROs to develop and maintain strong, collaborative relationships with key internal and external stakeholders.
- Support development of key study documents/databases
- Supports and facilitates the planning and execution of clinical studies on time, adhering to quality standards and within budget.
- Oversee the compliance of vendors established plans and quality/performance metrics.
- Apply a risk-based quality management system to proactively mitigate issues.
- Work cross functionally to drive project deliverables with internal and external stakeholders.
- Financial & budget management of clinical studies.
- Integrate clinical studies supply and logistics processes.
- Ensure study is conducted in accordance ICH/GCP standards & regulatory requirements.
- 2-5 years' clinical research experience of clinical studies within a pharma company, biotech or CRO.
- Excellent understanding of current and emerging ICH-GCP work practices and processes.
- Experience working on Phase 1 to 2 and 3 studies preferable.
- Experience in full clinical project lifecycle.
- Successfully worked with cross functional teams.
- A conscientious attitude with a 'can-do attitude' & prepared to work in a dynamic environment.
- Open, collaborative, proactive and cooperative
- Ability to manage key stakeholders across the business and work collaboratively with colleagues.
- Demonstrated ability to deliver results to the appropriate quality and timelines.
- Excellent interpersonal, communication and team management skills.
- Possess excellent risk management and problem-solving skills.
Full time or 4 days may be considered. Office based and WFH at times, with flexibility available to the right candidate.
To join our client in this new and exciting opportunity, please email your cover letter & CV to email@example.com. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.