• You have an experience in clinical trials and are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project.
• You are a dermatologist who 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

• Keep 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.
• Develop Medical Monitoring plan.
• Attend meetings with Innovaderm project team members (PM, DM, stats, CRO), as required.
•  Enter medical queries in EDC after lead medical monitor completes the subject safety-related data listings review.
• Enter potential protocol deviation identified by the medical monitors during safety data review in the study file.
• Support with coding listings of adverse events, medical history, and concomitant medications review to ensure all terms are coded properly.
• Support business development activities with proposal development and sales presentations.
• Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities.
• Perform other related duties as assigned or requested by the Director, Scientific and Regulatory Affairs.
• Maintain up to date study tracker, KPI tracker.
•  Develop and/or collect relevant medical monitoring team documentation, and track completion.
• Send documents for eSignature and file documents in the study folder/SharePoint.
• Develop content for project level medical Indication training (for each study), IM, team trainings.
• Coordinate team meetings and trainings.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

REQUIREMENTS

Education

• Medical degree; advanced training and experience in dermatology highly desirable.

Experience

• Minimum 1 year experience in CRO or pharmaceutical industry in clinical research; experience as medical monitor/medical reviewer/drug safety physician for clinical trials an asset.

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.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

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:

• Flexible work schedule
• Permanent full-time position
• Ongoing learning and development