Medical Monitor (US Board-Certified Gastroenterologist)
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Job Location:
Any - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and well-being.
Home-Based in the United States
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
- 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 lead 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.
Qualifications :
- Medical Doctor degree required
- US Board 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
Additional Information :
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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Time Management
- Diplomatic Skills
- Risk Management
- Influencing Skills
- Organizational Skill
- Accounting & Finance
- Strategy Management
- People Management
- Industril Knowledge
- Communication
- Negotiation Skills
- Strategic Thinking Skills
- Leadership Skill
- Problem Solving Skills
- Regulatory&Governance
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
