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    Medical Monitor Or Medical Monitor Ii

    Innovaderm Research
    5+ years
    Not Disclosed
    Canada
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/ MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Medical Monitor II, Canada – Medical Affairs

    Overview
    The Medical Monitor II will provide essential medical and scientific support for clinical research programs, working closely with clinical sites, sponsors, and internal teams to ensure adherence to study protocols and guidelines. This role is designed for professionals skilled at managing clinical trials while balancing strict protocol requirements and real-world scenarios, particularly in the dermatology field.

    Responsibilities

    Protocols and Projects

    • Stay current on study protocols, amendments, Investigator’s Brochure (IB), and clinical research guidelines.
    • Develop and review medical monitoring and safety reporting plans.
    • Provide project team training on study protocols and therapeutic areas.
    • Attend Investigators’ Meetings and provide medical consultation to Innovaderm team members throughout the study.
    • Contribute to business development activities, including bid defense meetings.

    Medical Dermatology Advisory Role

    • Provide 24/7 on-call service for urgent trial-related safety issues and medical questions regarding protocols and eligibility.
    • Advise clinical teams and investigators on safety concerns, protocol-related issues, and patient eligibility.
    • Evaluate and manage protocol deviations, prohibited medication interactions, and dropout replacements.
    • Serve as a subject matter expert for medical dermatology, offering guidance to internal teams, partners, and clients.

    Data Activities

    • Review safety-related data for trends, protocol deviations, AEs, and SAEs.
    • Assess stopping rules and necessary follow-up actions for study subjects.
    • Review clinical study reports and escalate safety/data integrity concerns to the Project Manager or Sponsor.
    • Analyze laboratory alerts and ensure appropriate follow-up with study sites.

    Safety Medical Monitoring and SAE Reporting

    • Verify the medical accuracy of subject safety data, continuously assessing the safety profile of the study.
    • Manage emergency unblinding code-breaks as needed and report any significant safety concerns.

    Ideal Profile

    Education

    • A Medical Degree (MD) is required. Candidates with medical education and training from outside Canada are encouraged to apply.
    • Note: This role is non-practicing, so no medical permit is required to practice medicine.

    Experience

    • A minimum of 5 years in clinical research, preferably within a CRO, pharmaceutical, or biopharmaceutical company, in roles such as Medical Monitor, Medical Affairs, or Safety.

    Knowledge and Skills

    • Excellent proficiency in oral and written English (additional languages are an asset).
    • Strong ability to work independently and in a team environment, balancing multiple projects with shifting priorities.
    • Excellent interpersonal, communication, and organizational skills are essential for working with diverse stakeholders.
    • Ability to translate complex medical concepts into practical solutions, promoting team consensus.

    Why Innovaderm?

    Work Environment and Benefits

    • Flexible work schedule.
    • Permanent, full-time position.
    • Comprehensive benefits package: medical, dental, vision, RRSP, vacation, personal days, and more.
    • Option to work from home anywhere in Canada or from Innovaderm’s headquarters in Montreal (subject to company policies and health guidelines).
    • Ongoing learning and professional development opportunities.

    About Innovaderm

    Innovaderm is a leading Contract Research Organization (CRO) specializing in dermatology. Established in 2000, Innovaderm has built a solid reputation for delivering high-quality research services that consistently exceed client expectations. Headquartered in Montreal, Innovaderm is expanding its reach across North America and Europe.

    Commitment to Equity
    Innovaderm is committed to providing equitable treatment and equal opportunity for all individuals. We offer accommodations throughout the recruitment process to applicants with disabilities, upon request.

    Note: Only candidates with the legal right to work in Canada will be considered.

    Recruitment Process

    Candidates will meet with Innovaderm team members via video conference as part of the recruitment process.

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