MEDICAL MONITOR (GASTROENTEROLOGY)

<p>As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.</p><p><u><strong>Full-time employment based in Australia</strong></u></p><p><strong>Responsibilities:</strong></p><ul><li>Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters</li><li>Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations</li><li>Review and analysis of clinical data to ensure the safety of study participants in clinical studies</li><li>Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments</li><li>Address safety issues across the study from sites and the study team</li><li>Participate in bid defense meetings</li><li>Assist in Pharmacovigilance activities</li><li>Identify Program risks, and create and implement mitigation strategies with Clinical Operations</li><li>Ability to organise and lead clinical development advisory boards and safety monitoring boards</li><li>Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines</li><li>Review and sign off clinical documents with respect to medical relevance</li></ul> <ul><li>Medical Doctor degree</li><li>Board-certification in Gastroenterology is preferred</li><li>Clinical experience in major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable&#xa0;</li><li>Prior experience in Clinical Research</li><li>Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority&#xa0;interactions leading to drug approval strongly preferred</li><li>Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization</li><li>Must possess excellent leadership, communication, presentation, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance</li><li>Proficiency with MS Office applications</li></ul> <p>Join our highly dedicated team of clinical research professionals with 250+ Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.</p>