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PSI CRO
Medical Monitor (Gastroenterology)PSI CRO • Sydney, New South Wales, Australia
Medical Monitor (Gastroenterology)

Medical Monitor (Gastroenterology)

PSI CRO • Sydney, New South Wales, Australia
8 days ago
Job description

As part of PSIs 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.


Remote Work :

Yes


Employment Type :

Full-time


Experience: years
Vacancy: 1

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Medical Monitor (Gastroenterology) • Sydney, New South Wales, Australia

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