Medical Monitor (Internal Medicine)
PSI CRO · Sydney
Descripcion del puesto
About the role
As a Medical Monitor (Internal Medicine) you will join PSI’s Medical Monitoring team, working alongside an international group of medical professionals to ensure the safety and scientific integrity of clinical studies. You will play a key part in translating complex medical data into clear documentation for patients, physicians, regulators and clients.
Key responsibilities
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third‑party vendors on medical matters.
- Collaborate with internal departments to prepare clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations.
- Review and analyse clinical data to ensure participant safety and compliance with approved protocols.
- Verify that reported data is accurate, complete and verifiable; address safety issues raised by sites and study teams.
- Review coded event listings using the Medical Dictionary for Regulatory Activities (MedDRA).
- Participate in bid defence meetings and support pharmacovigilance activities.
- Identify program risks and develop mitigation strategies with Clinical Operations.
- Organise and lead clinical development advisory boards and safety monitoring boards.
- Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines.
- Review and sign off clinical documents for medical relevance.
Required profile
- Medical qualification with expertise in internal medicine.
- Experience in clinical research, safety monitoring and pharmacovigilance.
- Strong knowledge of ICH, GCP and local regulatory requirements.
- Ability to communicate complex medical information clearly to diverse stakeholders.
Required skills
What we offer
- Opportunity to work on global clinical research projects with a leading CRO.
- Collaborative international environment focused on scientific excellence.
- Career development on the frontline of medical science.
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Publicado hace 17 horas
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PSI CRO
Sydney
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