Senior Medical Monitor (Remote - US)

MMS; Denver (CO); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

MMS, a leading data-focused clinical research organization, is seeking an experienced Medical Monitor to oversee Phase I–IV trials and observational studies. You will review safety data, monitor participant safety, and provide medical guidance across study teams in a global CRO environment.

The role requires an MD/DO or international equivalent, 5+ years of medical monitoring, strong regulatory knowledge (ICH, FDA, EMA), and excellent scientific writing.

Qualifications

• 5+ years of medical monitoring experience.
• Excellent knowledge of medical terminology and regulatory guidelines (ICH, FDA, EMA).
• Strong clinical data interpretation and writing skills.
• Ability to work with cross-functional teams and sponsors.
• Experience with protocol development and safety reporting.

Responsabilités

• Provide medical oversight for Phase I–IV trials and observational studies.
• Review eligibility, adverse events, safety data, and laboratory results.
• Support development of safety plans and regulatory documents.
• Respond to safety inquiries and provide medical guidance.
• Lead or participate in safety surveillance and signal management activities.

Connaissances

Medical monitoring

Regulatory knowledge

Communication skills

Clinical data interpretation

MS Office proficiency

Formation

Medical degree (MD/DO or international equivalent)

Outils

MS Office

Description du poste

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