Medical Monitor/moniteur Médical, Canada

4 months ago

Remote, Canada Innovaderm Research Full time

**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**
- 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 or review Medical Monitoring plan
- Provide project team training on study protocol and/or therapeutic area/indication.
- Prepare for, attend, and present at Investigators’ Meetings
- Prepare for and attend Safety Review Meetings, as needed
- Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters
- Provide ongoing medical support during the study to investigators, site personnel, and monitors
- Provide advice to the sites on protocol-related issues including: questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication
- Review lab critical values and alerts
- Provide emergency un-blinding code-break of randomized treatment assignment

**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
- 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
- Review clinical study report

**Data Activities**
- Participate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring
- Provide medical review of SAE form, and reviews SAE causality assigned by the Investigator.
- Write and/or review SAE narratives
- Work 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
- Serve as a non-voting member of the committee to convene and organize proceedings, as applicable

**Safety Medical Monitoring and SAE Reporting Activities**
- Provide assistance in pharmacovigilance activities
- Assist Innovaderm/Sponsor in choosing committee members
- Serve as a non-voting member to convene and organize proceedings, as applicable
- Develop operating guidelines in conjunction with committee members and submit these to Sponsor for review
- Support business development activities with proposal development and sales presentations.
- Participate in feasibility discussions relating to specific project proposals
- 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
- Perform other related duties as assigned or requested by the Chief Medical Officer.

**Requirements**:
**PROFILE**

**Education
- Medical degree;
- Completed residency training in either Dermatology or Rheumatology

**Experience
- Minimum 3 years experience in CRO or pharmaceutical industry in clinical research, with experience as medical monitor/medical reviewer/drug safety physician for clinical trials
- At least 3 years of experience as Medical Monitor which should include dermatology and/or rheumatology studies
- being trained/board certified as a dermatologist or a rheumatologist is a plus

**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 mínimal 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 knowled

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