Reporting to the Director, Scientific and Regulatory Affairs, the Medical Monitor provides medical and scientific support to clinical research programs.
The Medical Monitor will perform the following activities, as required by the projects’ scope of work :
Clinical Activities :
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 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 support 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.
Provides project-related medical consultation to the Innovaderm project team members during normal business hours throughout the duration of the study.
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.
Data Activities :
Works with the data management team to reconcile serious adverse events (SAEs) , as needed.
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.
Reviews protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends.
Reviews coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly.
Assesses if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable.
Reviews portions of clinical study report, as required.
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.
Prepares for and attend the Safety Review Meeting, as needed.
Provides medical review of SAE form, and reviews SAE causality assigned by the Investigator.
Assigns SAE expectedness against the approved Prescribing Information / IB, in consultation with the Sponsor.
Writes and / or review SAE narratives
Works with the Pharmacovigilance Services provider or Marketing Authorization Holder (MAH) to review SAEs and follow-up on outstanding safety queries, interact with Sponsor and discuss safety issues with sites, as needed.
Reviews IND / SUSAR Safety Reports, update to IB, and annual IND reports with Sponsor data.
Provides emergency unblinding code-break of randomized treatment assignment, as applicable.
Data Safety Monitoring Board (DSMB) / Adjudication Committee Activities :
Assists Innovaderm / Sponsor in choosing committee members.
Serves as a non-voting member to convene and organize proceedings, as applicable.
Develops operating guidelines in conjunction with committee members and submit these to Sponsor for review.
Determines data flow with Sponsor to ensure reporting accuracy.
Ensures DSMB feedback is given to sites for IRBs.
Business Development Activities
Supports business development activities with proposal development and sales presentations.
Participates in feasibility discussions relating to specific project proposals.
Special Projects :
Assists with drafting of standard operating procedures and working practices regarding Medical Monitoring activities.
Performs other related duties as assigned or requested by the Director, Scientific and Regulatory Affairs.
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.
In possession of Medical degree, specialization in dermatology an asset.
Bilingual (English and French) with excellent written English skills.
Minimum of 5 years of experience of biopharmaceutical industry experience in drug development and clinical research.
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.