Medical Monitor (Board-certified, Internal Medicine)
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
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 and Board-certified specialist in Internal Medicine.
- Prior and wide 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 :
No
Employment Type :
Full-time
Key Skills
- Dermatology
- Marketing and Merchandising
- Corporate Risk Management
- Kpo
- Accident Investigation
- Content Management
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
