Medical Science Advisor
vor 3 Wochen
Job Title: Medical Monitor
Job Summary:
PSI is seeking a highly skilled Medical Monitor to provide medical input to global clinical studies and advise teams and business partners on medical matters. As a Medical Monitor, you will be responsible for ensuring the safety of study participants and ensuring that reported data is accurate, complete, and verifiable.
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.
- Canada 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.
About PSI:
As a member of PSI's 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 who need them.
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