About the Role
Provide expert medical guidance and oversight for clinical trials, focusing on patient safety, protocol compliance, and data interpretation within gastroenterology studies.
Responsibilities
- Monitor patient safety throughout clinical trial phases
- Review and assess adverse event reports promptly
- Ensure study protocols are medically sound and followed
- Collaborate with clinical teams on medical decision-making
- Support investigator queries with timely medical input
- Evaluate eligibility of participants based on medical criteria
- Assist in developing trial medical monitoring plans
- Review clinical data for medical trends or risks
- Advise on medical aspects of study design
- Contribute to safety reporting for regulatory submissions
- Participate in investigator meetings and training
- Review informed consent forms for medical accuracy
- Support risk management and mitigation strategies
- Provide medical input during audits and inspections
- Collaborate with pharmacovigilance teams
- Review protocol deviations with medical context
- Guide medical aspects of study timelines
- Assess need for dose modifications or study changes
- Ensure compliance with ethical and regulatory standards
- Support cross-functional team medical discussions
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid or remote with travel to study sites as required
Team
Collaborative environment with clinical operations, data management, and regulatory teams
Therapeutic Focus
- Specialized in gastrointestinal disorders and liver diseases
- Experience in inflammatory bowel disease and motility disorders
Regulatory Environment
- Knowledge of Health Canada regulations
- Experience with clinical trial applications and amendments
Technology Proficiency
- Experience with EDC and CTMS platforms
- Familiarity with safety databases and medical coding systems
Professional Development
- Opportunities for ongoing training in clinical research
- Access to scientific conferences and workshops
Not applicable; candidate must be authorized to work in Canada
