Senior Medical Monitor (Remote - US)

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 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.

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+ 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.