Medical Monitor or Medical Monitor II

Reporting to the Manager Medical Monitor, Medical Affairs, the Medical Monitor or Medical Monitor II, Canada 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.

RESPONSIBILITIES

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 dermatology advisory role

• 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.
• Participates actively and presents in bid defense meetings.
• Acts as an advisor and subject matter expert for tasks requiring a medical dermatology expertise (review of documents, advising colleagues, partners and clients).

Data Activities

• 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.

REQUIREMENTS

Education

• Medical degree (MD). Candidates with medical education and training completed outside of Canada are accepted and encouraged to apply.
• Note that this position does not require a permit to practice medicine (non-practicing physician role).

Experience

• Minimum of 5 years of 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.
• 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 oral and written communication skills as well as interpersonal skills are essential.

OUR COMPANY

The work environment

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.

In this position, you will be eligible for the following perks:

• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Option to work from home anywhere in Canada or from our headquarters in Montreal (in accordance with company policies and public health directives)
• Ongoing learning and development

About Innovaderm

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, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm only accepts applicants who can legally work in Canada.