Medical Monitor

About the role

Join PSI’s Medical Monitoring team in Australia and work alongside an international group of medical professionals. You will play a pivotal role in ensuring the safety of participants and the scientific integrity of clinical trials, helping bring new medicines to patients.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
• Collaborate on clinical development plans, protocols, investigator brochures, reports, manuscripts and scientific presentations.
• Review and analyse clinical data to ensure participant safety and protocol compliance.
• Address safety issues, support pharmacovigilance activities and participate in bid defense meetings.
• Identify program risks, develop mitigation strategies and organise advisory and safety monitoring boards.
• Ensure compliance with local regulatory agencies, ICH and GCP guidelines and sign‑off on medically relevant documents.

Required profile

• Medical Doctor degree.
• Board certification in a therapeutic area (e.g., Oncology, Infectious Disease, Gastroenterology, Hematology, Internal Medicine) – desirable.
• Prior experience in clinical research and interaction with health authorities.
• Ability to train clinical monitors and physician investigators and build collaborative relationships.
• Strong leadership, communication and presentation skills.

Required skills

• Pharmacovigilance
• Clinical data analysis
• ICH and GCP compliance
• Safety monitoring and risk mitigation
• Regulatory affairs knowledge

What we offer

• Full‑time employment in a globally recognised CRO.
• Inclusive and diverse work environment.
• Opportunities to contribute to groundbreaking pharmaceutical advancements.