Clinical Project Lead - AI, Imaging & Regulatory

Lead Group; Western Australia; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Lead Group is seeking a Clinical Project Associate to join our innovative MedTech environment where clinical research, medical imaging and AI-driven technology intersect. You will help plan and deliver clinical studies and regulatory submissions, contributing to AI development and scientific publications.

The role offers exposure to technology, product development and medical imaging while supporting operational study delivery and cross-functional collaboration across Clinical Development, R&D

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Engineering or a related discipline.
• 3+ years of relevant professional experience in clinical research or similar.
• 1–3 years' experience in project management involving clinical research or other projects.
• Familiarity with international clinical research regulations and ethical standards, including ICH-GCP.
• Strong organizational skills and attention to detail.
• MS Word and Excel proficiency; MS Project exposure would be beneficial.

Responsibilities

• Support the day-to-day delivery of clinical studies and research projects.
• Coordinate with CROs, clinical sites, investigators and external vendors.
• Assist with study start-up, monitoring, project tracking and reporting.
• Support the development of study protocols, project plans, training materials and regulatory documentation.
• Assist with image and clinical data management processes.
• Monitor study deviations, trends, data readiness and data quality.
• Maintain TMF and other study documentation.
• Collaborate across Clinical Development, R&D and Quality/Regulatory teams.
• Contribute to cardiac CT image analysis and image-analysis methodology development if applicable.

Skills

3+ years experience

1–3 years project management

ICH-GCP familiarity

strong organizational skills

attention to detail

Education

Bachelor's degree in Life Sciences or Biomedical Engineering

Tools

MS Word

MS Excel

MS Project

Job description

Lead Group is seeking a Clinical Project Associate to join our innovative MedTech environment where clinical research, medical imaging and AI-driven technology intersect. You will help plan and deliver clinical studies and regulatory submissions, contributing to AI development and scientific publications.

The role offers exposure to technology, product development and medical imaging while supporting operational study delivery and cross-functional collaboration across Clinical Development, R&D