Clinical trials are a crucial part of drug development, and as a clinical trial manager you will play a vital role in ensuring their successful execution.
About the Role:
As a lead clinical trials coordinator, you will be responsible for leading and managing the conduct of clinical trials from start-up to closeout in accordance with ICH-GCP and local regulations. This includes ensuring effective study risk management for assigned studies in Australia.
You will collaborate with cross-functional internal and external stakeholders to ensure timely and on-budget execution of clinical trial deliverables. Additionally, you will be responsible for the leadership of a regional matrix team to ensure delivery of country and site level study activities in alignment with the global study project plan.
Main Responsibilities:
* Develop and implement strategies for study TMF completeness, quality and inspection readiness
* Oversee the conduct of clinical trials, including planning, coordination and execution
* Ensure compliance with regulatory requirements and industry standards
* Maintain accurate records and reports of clinical trial progress
* Identify and mitigate potential risks to clinical trial success
Requirements:
* Tertiary Degree qualified in Healthcare/Science or related field
* Previous clinical trial oversight/leadership experience as a Clinical Trial Manager/Project Manager within CRO or pharmaceutical industry is essential
* Prior experience working on Oncology and Vaccine trials within CRO/pharmaceutical industry is beneficial
* You are confident working autonomously to ensure delivery of expectations
* Strong communication and relationship building skills
* Good multitasking, time management and prioritisation skills
What We Offer:
We value diversity and inclusion and strive to create an environment that is free from discrimination and harassment, where all candidates can thrive. If you require a reasonable accommodation during the application process, please let us know through our website.