Medical Monitor (US reputed company-Certified Gastroenterologist)
PSI Medical Monitors reputed company medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and reputed company-being.
Home-Based in the reputed company
Responsibilities:
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and reputed company-party vendors on medical reputed company
- 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 reputed company, 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 organize and reputed company clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.
- Medical Doctor degree required
- US reputed company Certification in Gastroenterology required
- Experience as a practicing Gastroenterology (minimum of 10 years)
- Full working proficiency in English
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the reputed company of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We reputed company on delivering reputed company and on-time services across a reputed company of therapeutic indications.
Originally posted on Himalayas
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