Senior Clinical Research Associate overseeing clinical trial sites for Novo Nordisk, a pharmaceutical company developing treatments for chronic diseases. Ensuring compliant monitoring, patient safety, data integrity and timely study execution.
About the role
- Canada-based Gastroenterologist serving as PSI Medical Monitor. Providing medical and safety oversight across global clinical studies and supporting trial teams, sponsors, and regulators.
Responsibilities
- Act as the primary medical and safety contact for all parties on trial-specific questions
- Provide input to regulatory authorities and IRBs/IECs
- Monitor trial participant safety
- Support participant recruitment and retention activities
- Present medical matters at kick-off and investigator meetings
- Train trial teams on the therapeutic area and protocol medical aspects
- Develop and review trial-specific medical-monitoring documents
- Manage ongoing medical-monitoring risks
- Perform ongoing medical review of operational clinical trial databases
- Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and annual IND reports
- Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation
- Participate in IDMC and adjudication committees
- Review clinical study reports, including safety narratives and TFLs
- Prepare for and participate in trial audits and follow up on findings
- Participate in feasibility assessments, bid defense meetings, and client interactions
- Act as a medical expert and provide therapeutic expertise to PSI departments
Requirements
- Medical Doctor degree required
- Canada Board Certification in Gastroenterology required
- Minimum of 10 years of experience as a practicing Gastroenterologist
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation, and analytical skills
- Problem-solving, team-oriented, and detail-oriented
- Willingness/ability to provide medical expertise for global clinical studies and related trial activities
Benefits
- Remote work / home-based work in Canada
- Full-time employment
- Opportunity to join an international group of medical professionals
- Career development on the frontline of medical science
- Opportunity to use medical expertise to help bring new medications to patients
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