Remote opportunity at
MMSSenior Medical Monitor (Remote - Canada)
MMS, an award-winning data-focused clinical research organization recognized as a Great Place to Work Certified company, is seeking a remote Senior Medical Monitor based in Canada.…
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About This Role
MMS, an award-winning data-focused clinical research organization recognized as a Great Place to Work Certified company, is seeking a remote Senior Medical Monitor based in Canada. The organization assists pharmaceutical, biotechnology, and medical device companies with complex trial data and regulatory submissions across four continents. This role suits professionals with a medical degree and extensive experience in medical monitoring who can provide oversight for clinical trials and observational studies. The…
Job Description
MMS, an award-winning data-focused clinical research organization recognized as a Great Place to Work Certified company, is seeking a remote Senior Medical Monitor based in Canada. The organization assists pharmaceutical, biotechnology, and medical device companies with complex trial data and regulatory submissions across four continents. This role suits professionals with a medical degree and extensive experience in medical monitoring who can provide oversight for clinical trials and observational studies.
The person in this position delivers medical guidance throughout study execution, handles safety surveillance and signal management, and acts as a primary medical reviewer for adverse event reports. Responsibilities also include contributing to protocol creation, reviewing safety sections in regulatory filings, and serving as a medical subject matter expert for sponsors and project teams.
Responsibilities
- Deliver medical oversight for Phase I-IV clinical trials and observational studies
- Evaluate participant eligibility, protocol deviations, adverse events, lab data, and vital signs
- Contribute to protocol development, Investigator Brochures, Medical Monitoring Plans, and Safety Management Plans
- Address site safety inquiries and provide medical guidance during study conduct
- Engage in Data Monitoring Committees, Safety Review Committees, and cross-functional team meetings
- Serve as primary medical reviewer for individual adverse event reports
- Direct adverse event coding, retrieval, and analysis activities
- Manage aggregate case analysis, safety summaries, and safety signal generation
- Conduct medical and technical reviews of safety sections in regulatory documents and NDA/BLA submissions
- Oversee regulatory reporting including individual case safety reports, annual report summary statements, and periodic safety update reports
- Participate in safety surveillance and signal management initiatives
- Act as a medical subject matter expert for sponsors and internal project teams
Requirements
- Minimum of 5 years of medical monitoring experience, clinical experience, and or research experience
- Strong proficiency with MS Office applications
- Capability to function independently and integrate with client clinical and safety teams
- Familiarity with protocol amendments and ICF updates
- Background in aggregate data review for ongoing clinical trials
- Experience as a clinical scientist handling clinical trial data assessment and safety surveillance for Phase I-III studies
Qualifications
- Medical degree such as MD, DO, or international equivalent
- Thorough understanding of medical terminology, clinical pharmacology, and regulatory guidelines including ICH, FDA, and EMA
- Advanced scientific writing abilities
- Strong comprehension of clinical data
- Comprehensive knowledge of current regulatory practices and domestic and international regulations
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, this role is listed as a remote position based in Canada.
What education is required for this role?
Candidates must hold a medical degree such as an MD, DO, or an international equivalent.
How many years of experience are needed?
The posting requires 5 or more years of medical monitoring experience, clinical experience, and or research experience.
What is the salary for this position?
The provided job posting does not specify the salary for this role.
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