Medical Monitor/Moniteur Médical (Canada)

at  Innovaderm Research

The Medical Monitor provides medical and scientific support to clinical research programs. The Medical Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed.

This role will be perfect for you if:

• You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project
• You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials
• You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary

EDUCATION

• Medical degree;

EXPERIENCE

• Minimum 3-5 years experience in CRO or pharmaceutical industry in clinical research, with experience as medical monitor/medical reviewer/drug safety physician for clinical trials

KNOWLEDGE AND SKILLS

• Excellent knowledge of the drug development process.
• Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
• Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Client-focused approach to work;
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  Our company:

MEDICAL DERMATOLOGY ADVISORY ROLE

• Provide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study
• Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact
• Attend meetings with Innovaderm project team members (PM, DM, stats, CRO) and/or Sponsor, as required
• Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study
• Review subject safety-related data listings for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; and address safety concerns
• Review protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends
• Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly
• Assess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable
• Review clinical study report

This role will be perfect for you if:

• You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project
• You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials
• You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessar