About The Position
Reporting to the Director, Scientific and Regulatory Affairs, the Medical Monitor provides medical and scientific support to clinical research programs.
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.
Protocols and projects
- Keeps current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication.
- Develops or reviews medical monitoring plan, and review safety reporting plan as appropriate.
- Provides project team training on study protocol and/or therapeutic areas.
- Prepares for and attend Investigators’ Meetings.
- Provides project-related medical consultation to the Innovaderm project team members during normal business hours throughout the duration of the study.
- Participate in activities related to business development (bid defense).
Medical advisory role (clinical sites)
- Provides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns.
- Provides first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues.
- Provides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial.
- Assesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject.
- Evaluates the appropriateness of any dropout subject replacement.
- Reviews 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.
- Assesses if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable.
- Reviews laboratories alerts, and coordinate appropriate follow-up with study sites.
- Reviews portions of clinical study report, as required.
- Escalates 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.
Safety Medical Monitoring and SAE Reporting Activities
- Verifies the medical accuracy of subject safety data and maintains an ongoing assessment of the safety profile of the study.
- Provides emergency unblinding code-break of randomized treatment assignment, as applicable.
- In possession of Medical degree (MD). Medical degree can be completed outside of Canada (non-practising physician).
- Minimum of 5 years of relevant experience in clinical research in a CRO, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety).
Knowledge and skills
- Excellent oral and written English communication skills, additional languages are an asset.
- Strong interpersonal skills and ability to communicate effectively with sites, colleagues and clients.
- 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.
At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Medical Monitor, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Canada, Innovaderm continues to grow and expand in North America and Europe.