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Precision Medicine Group
Regulatory And Site Start Up Specialist
Remote · Australia · Mid level
About the role
The Regulatory and Site Start Up Specialist manages regulatory and site start-up activities for clinical trials, ensuring timely submissions and site activation readiness. They support regulatory compliance, document collection, and site collaboration to facilitate clinical trial execution.
What you’ll do
• Prepare clinical trial submission dossiers. • Interact with Competent Authorities and Ethics Committees. • Maintain project plans and regulatory intelligence tools. • Support site contract and budget negotiations. • Act as subject matter expert for site start-up activities.
What you’ll bring
• Bachelor’s degree in life sciences or related field. • 1+ year experience in regulatory or site start-up role. • Strong communication and organizational skills. • Experience with electronic information systems. • Fluency in English and local language.
Life at Precision Medicine Group
Precision Medicine Group offers a collaborative environment focused on oncology and rare disease clinical trials with opportunities for training and mentoring.
About Precision Medicine Group
Precision Medicine Group integrates clinical trial execution with scientific knowledge and data sciences to accelerate life-changing therapies in oncology and rare diseases.