Senior Medical Monitor (Remote - Canada)

MMS Holdings Inc; Calgary; Remote; CAD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc is seeking a Medical Monitor to provide medical oversight for Phase I–IV trials and observational studies. You will review safety data, assess protocol deviations and adverse events, and support regulatory submissions.

You will guide AE coding and analysis while collaborating with cross-functional teams across the sponsor and site networks. The role requires an MD/DO or international equivalent, 5+ years of medical monitoring experience, and strong knowledge of ICH, FDA, and EMA

Qualifications

• MD/DO or international equivalent required.
• 5+ years of medical monitoring experience.
• Experience with protocol amendments and ICF updates.
• Experience with aggregate data review for ongoing trials.
• Excellent knowledge of regulatory guidelines (ICH, FDA, EMA).
• Excellent scientific writing skills.

Responsibilities

• Provide medical oversight for Phase I-IV trials and observational studies.
• Review eligibility, protocol deviations, adverse events, lab data, vital signs, and safety data.
• Support protocol development and related safety plans.
• Respond to safety inquiries and provide medical guidance during study conduct.
• Participate in DMCs and cross-functional study team meetings.
• Collaborate with other service lines and teams.
• Act as primary medical reviewer of adverse event reports.
• Guide adverse event coding, retrieval and analysis in safety reviews.
• Lead safety activities and monitor cumulative safety information.
• Provide regulatory and safety reviews for NDA/BLA submissions.
• Coordinate data-related safety documents for regulatory authorities.

Skills

Communication skills

Scientific writing

Regulatory knowledge

Data interpretation

Cross-functional collaboration

Medical terminology

Education

MD/DO or international equivalent

Tools

MS Office

Job 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

• 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 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.

Job Requirements

• 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.