Senior Medical Monitor (Remote Canada)

About MMS
Are you looking to join a company where your contributions truly matter and where youll 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.

• 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 Investigators 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 inthecompany.
• 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 reportsummary 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 yearsof 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.

Required Experience:

Senior IC