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Medical Monitor, Dermatology, Europe
Contract type
Ongoing
Work mode
Remote · Europe
Experience
Mid-level · 2+ years
Job description
Medical Monitor for dermatology clinical research programs, providing medical and scientific support, safety oversight and data review for clinical trials. The role involves acting as medical advisor to clinical sites, investigators and project teams.
At a glance
- Employment
- Full-time · Employee (employment agreement)
- Work mode
- Remote · Europe
What you'll do
- Keep current on study protocol, protocol amendments, Investigator's Brochure, additional safety information and relevant clinical research guidelines for 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 service for urgent safety-related matters
- Provide ongoing medical support during the study to investigators, site personnel, and monitors
- Advise sites on protocol-related issues including inclusion/exclusion criteria, concomitant medications/medical conditions, follow-up visits and prohibited medication
- Review lab critical values and alerts
- Assess the impact of any prohibited medication taken on study and evaluate appropriate action for the subject
- Evaluate the appropriateness of any dropout subject replacement
- Provide emergency unblinding code-break of randomized treatment assignment
- Provide first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of protocol and subject eligibility issues
- Provide project-related medical consultation to Indero project team members during business hours throughout the study
- Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns
- Attend meetings with Indero project team members (PM, DM, stats, CRO) and/or Sponsor as required
- Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study
- Review subject safety-related data listings/tools to identify potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs
- Review protocol deviation listings to address potential safety concerns, perform impact assessment and identify potential trends
- Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly
- Assess if any stopping rule was met and evaluate appropriate action or follow up with the subject
- Review clinical study report
- Participate in Central Monitoring activities with site data signal detection and risk management for the safety portion; participate in safety review for RBM and central monitoring
- Provide medical review of SAE form and review SAE causality assigned by the Investigator
- Write and/or review SAE narratives
What we're looking for
- Medical degree
- Minimum of 2 years of relevant experience in clinical research in a CRO, dermatology clinical trials, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety)
- Dermatology
- 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
- Client-focused approach to work
- Good knowledge of good clinical practices
- Skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project
- Ability to balance the strict requirements of clinical research protocols with the realities of clinical trials
- Ability to interpret high volumes of data and situations efficiently, and take position and advise as necessary
- Must be able to legally work in Europe
Benefits
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
Apply
About Indero
Contract research organization (CRO) specialized in dermatology
Indero, formerly Innovaderm, is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, the organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Key facts
- 2000
- Montreal
- Contract research organization (CRO) specialized in dermatology
- Formerly known as Innovaderm
- Specialized in dermatology
- Growing and expanding in North America and Europe
- Only accepts applicants who can legally work in Europe
What they value
- Collaboration
- Innovation
- Reliability
- Responsiveness