Publié hier
Senior Medical Monitor (Remote - Canada)
@ MMS
Toronto, Ontario
SIGNAUX
En bref
MMS, a data-focused clinical research organization, is hiring a Senior Medical Monitor to work remotely in Canada on a full-time basis. The role provides medical oversight for Phase I-IV clinical trials and observational studies, including safety review, adverse event assessment and regulatory submissions. Candidates need a medical degree and at least 5 years of medical monitoring, clinical or research experience.
Responsabilités :
- Provide medical oversight for Phase I-IV clinical trials
- Review adverse events, labs, vital signs and safety data
- Support protocol and Investigator's Brochure development
- Guide safety reporting and regulatory submissions
- Participate in Data Monitoring and Safety Review Committees
Résumé des exigences :
- Medical degree (MD, DO or equivalent)
- 5+ years of medical monitoring, clinical or research experience
- Knowledge of ICH, FDA and EMA regulations
- Excellent scientific writing skills
- Proficiency with MS Office
Outils et compétences
Source et dates
Site carrière / système de candidatures · jazzhr
- Date publiée par l’employeur
- 2026-11-11
- Première détection par notre source
- 2026-11-12
- Mise à jour du dossier source
- 2026-11-12
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Senior |
| Domaine | Médecins et pratique avancée |
| Expérience | 5 an(s) et plus |
| Heures par semaine | 40 (estimé) |
| Milieu de travail | Domicile |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
| Formation | Diplôme professionnel (médecine, droit…) (exigé) |
| Domaines d’études | Medicine |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
| Champ | Valeur |
|---|---|
| Offres sur Jobsy | 3 |
Description
About MMS
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles and Responsibilities
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles and Responsibilities
- Provide medical oversight for Phase I-IV clinical trials and observational studies.
- Review participant eligibility, protocol deviations, adverse events, laboratory data, vital signs, and other safety-related clinical data.
- Support protocol development, Investigator's Brochures, Medical Monitoring Plans, Safety Management Plans, and other clinical study documents.
- Respond to investigator and site safety inquiries and provide medical guidance throughout study conduct.
- Participate in Data Monitoring Committees, Safety Review Committees, and cross-functional study team meetings.
- Works cross-functionally with team members in other service lines.
- Provide significant expertise as primary medical reviewer of individual adverse event reports.
- Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials.
- Aggregate case analysis, safety summaries and safety signal generation.
- Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company.
- Responsible for strategies in monitoring and analysis of cumulative safety information.
- Provide medical and technical reviews of safety sections of regulatory documents and NDA/BLA submissions.
- Guide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs).
- Guide and coordinate preparation of ad-hoc benefit-risk assessment documents.
- Lead and/or participate in safety surveillance and signal management activities
- Guide safety updates of company core data sheet and local product labels.
- Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees.
- Serve as a medical subject matter expert for sponsors and project teams.
- Ability to work independently as well as able to integrate with client clinical and safety teams.
- Medical degree (MD, DO, or international equivalent),
- Experience with protocol amendments and ICF updates.
- Experience with aggregate data review for ongoing clinical trials.
- Experience as a clinical scientist who is responsible for timely assessment of the clinical trial data and participation in safety surveillance activities for assigned studies in Phase I-III, including review of medical history, labs, vital signs, medications, and prohibited medications.
- 5+ years of medical monitoring experience, clinical experience and/ or research experience required.
- Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA).
- Excellent scientific writing skills.
- Ability to understand clinical data.
- Proficiency with MS Office applications.
- Strong communication skills.
- Strong knowledge of current regulatory practices and domestic and international regulations.
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