Medical Monitor (Gastroenterology)

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PSI CRO is seeking a Medical Monitor with a gastroenterology focus for a full-time onsite role in Sydney. You will advise on medical matters to clients, sites and regulators; collaborate on development plans and study documents; review data for safety and protocol compliance; address safety issues; participate in bid defenses and pharmacovigilance; identify risks and implement mitigations with Clinical Operations; organize and lead advisory and safety monitoring boards; ensure local regulatory and ICH/GCP compliance and sign off on medical documents. To apply, tailor your CV to emphasize gastroenterology expertise, CRO/clinical trial experience, regulatory interactions, leadership and training ability, and willingness to work onsite in Australia, with concrete examples of risk mitigation.

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

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.

Full-time employment based in Australia

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• 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
• Address safety issues across the study from sites and the study team
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to 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 with respect to medical relevance

Qualifications

• Medical Doctor degree
• Board-certification in Gastroenterology is preferred
• Clinical experience in major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable 
• Prior experience in Clinical Research
• Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly preferred
• 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
• 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
• Proficiency with MS Office applications

Additional Information

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.