Medical Monitor

About the role

PSI, a leading global CRO, is seeking a Medical Monitor to join its Medical Monitoring team in Australia. You will work with an international group of medical professionals, applying your clinical expertise to ensure the safety of study participants and support the delivery of high‑quality clinical trials.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
• Collaborate on clinical development plans, protocols, investigator brochures, annual reports, study reports, manuscripts and scientific presentations.
• Review and analyse clinical data to confirm participant safety and data integrity.
• Address safety issues, support pharmacovigilance activities and ensure compliance with ICH and GCP guidelines.
• Organise and lead clinical development advisory boards and safety monitoring boards.
• Participate in bid defence meetings and identify program risks with mitigation strategies.
• Review and sign off clinical documents for medical relevance.

Required profile

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

Required skills

• Pharmacovigilance
• Clinical data analysis
• Regulatory compliance (ICH, GCP)
• Medical writing
• Safety monitoring board facilitation

What we offer

• Inclusive, diverse work environment.
• Global CRO with 30 years of industry experience.
• Opportunities to contribute to groundbreaking pharmaceutical advancements.