Global Clinical Study Advisor
Vor 5 Tagen
Our Medical Monitoring team is composed of experienced medical professionals who provide critical input to global clinical studies. As a Global Clinical Study Advisor, you will work closely with this team to ensure the safety and integrity of clinical studies.
Main Objectives:
- Provide expert medical input to global clinical studies and advise on clinical development plans, protocols, and investigator brochures
- Collaborate with internal departments to prepare clinical study reports, manuscripts, and scientific presentations
- Review and analyze clinical data to ensure the safety of study participants
- 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
Requirements:
- 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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