Medical Science Specialist
Vor 7 Tagen
Company Overview:
As a leading provider of medical services, we are committed to delivering high-quality care and expertise to patients worldwide. Our team of medical professionals is dedicated to providing innovative solutions to complex clinical challenges.
Job Summary:
We are seeking a highly skilled Gastroenterology Expert to join our Medical Monitoring team as a Global Clinical Study Advisor. The successful candidate will provide critical input to global clinical studies, collaborate with internal departments, and ensure the safety and well-being of study participants.
Responsibilities:
- Advise clients, project teams, and regulatory agencies on medical matters related to clinical development plans, protocols, and investigator brochures
- Collaborate with internal departments to prepare annual reports, clinical study reports, manuscripts, and scientific presentations
- Review and analyze clinical data to ensure the safety of study participants in clinical studies
- Verify the accuracy, completeness, and verifiability of reported data and ensure compliance with approved protocols and amendments
- Address safety issues across the study from sites and the study team
- Assist in Pharmacovigilance activities and identify Program risks
- 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 Gastroenterologist (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
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