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Medical Monitor, Canada Board-Certified Psychiatrist
PSI CRO AG. Act as the primary point of contact for trial-specific medical and safety-related questions .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical monitoring and safety oversight within clinical trials, with a strong focus on participant safety, regulatory compliance, and effective communication. Proven ability to train teams, manage trial risks, and provide medical expertise across various trial-related activities.
Highest-signal resume keywords
Medical Doctor DegreeCanada Board Certification In PsychiatryClinical Research ExperienceMedical MonitoringRegulatory Compliance
ATS Keywords
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Hard Skills
Medical ReviewProtocol Deviation ReviewSafety Report ReviewData ManagementTrial Risk ManagementParticipant RecruitmentTrial Audit PreparationFeasibility AssessmentSafety Narrative ReviewClinical Study Report Review
Soft Skills
Communication SkillsPresentation SkillsAnalytical SkillsProblem-SolvingTeam-OrientedDetail-Oriented
Tools & Technologies
MS Office Applications
Certifications & Qualifications
Canada Board Certification In Psychiatry
Industry Keywords
Clinical TrialsPharmacovigilanceIRBIECINDSUSARIDMCAdjudication Committees
About the role
Key responsibilities & impact- Act as the primary point of contact for trial-specific medical and safety-related questions
- Provide input for responses to regulatory authorities and IRBs/IECs
- Monitor trial participant safety
- Participate in participant recruitment boost and retention activities
- Present on medical matters at kick-off and investigator meetings
- Train trial teams in the therapeutic area and medical aspects of protocols
- Develop and review trial-specific documents within medical monitoring scope
- Manage ongoing trial risks related to medical monitoring
- 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 trial-related committees such as IDMC and adjudication committees
- Review clinical study reports, including safety narratives and TFLs
- Provide medical expertise on an as-needed basis
- Prepare for and participate in trial audits and follow up on audit findings
- Participate in feasibility assessments of potential and ongoing trials in Canada/region
- Participate in bid defense meetings and client interactions
- Act as a medical expert and provide therapeutic expertise to other PSI departments
Requirements
What you’ll need- Medical Doctor degree required
- Canada Board Certification in psychiatry required
- Minimum of 10 years of experience as a practicing psychiatrist
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team-oriented and detail-oriented
- Based anywhere in Canada
Benefits
Comp & perks- Part-time/consultant role
- Remote work from anywhere in Canada
- Opportunity to join PSI's international group of medical professionals
- Career development on the frontline of medical science
- Opportunity to use medical knowledge and expertise to help bring new medications to patients