Medical Monitor
Medical Monitor
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Job Description
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.
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 (MD) degree with Board Certification/Specialization in (Oncology Gastroenterology Infectious Disease or OncoHematology) is an essential requirement.
- 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 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
