Medical Monitor (Infectious Disease)
Medical Monitor (Infectious Disease)
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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.
Candidates outside of Sydney are welcome to apply.
Responsibilities:
- Advise clients project teams sites data safety monitoring boards regulatory agencies and thirdparty 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
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- 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
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.
Qualifications :
- Medical Doctor degree board certified/completed Fellowship in Infectious Disease.
- Prior experience in clinical research/clinical trials.
- Familiar and comfortable with clinical concepts practices and local regulations regarding clinical research trials experience with TGA 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 organisation.
- Must possess excellent leadership communication presentation and organisational skills and be able to exercise sound critical thinking and problemsolving 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 :
No
Employment Type :
Fulltime
Employment Type
Full-time
