MMS

Regulatory compliance and data solutions provider

Senior Medical Monitor

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRemote in USANo salary listedRemote

About the Job

Requirements

A medical degree (MD, DO, or international equivalent) is required.
Experience with protocol amendments and informed consent form updates is required.
Experience with aggregate data review for ongoing clinical trials is required.
Experience as a clinical scientist responsible for timely clinical trial data assessment and participation in safety surveillance activities for assigned Phase I–III studies is required, including review of medical history, laboratory results, vital signs, medications, and prohibited medications.
At least five years of medical monitoring, clinical, and/or research experience is required.
Knowledge of medical terminology, clinical pharmacology, and regulatory guidelines, including ICH, FDA, and EMA guidance, is required.
Scientific writing skills are required.
Ability to understand clinical data is required.
Proficiency with Microsoft Office applications is required.
Knowledge of current regulatory practices and domestic and international regulations is required.

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 development of protocols, 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.
Work cross-functionally with team members in other service lines.
Serve as the primary medical reviewer for individual adverse event reports, providing significant medical expertise.
Guide adverse event coding, retrieval, and analysis activities in drug safety and clinical trials.
Conduct aggregate case analysis, prepare safety summaries, and generate safety signals.
Lead safety activities for assigned products, including interactions with other company functional groups as applicable.
Develop strategies for monitoring and analyzing cumulative safety information.
Provide medical and technical reviews of safety sections in 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 to company core data sheets and local product labels.
Guide regulatory strategy and preparation of safety-related data for regulatory authorities and advisory committees.
Serve as a medical subject matter expert for sponsors and project teams.
Work independently and integrate with client clinical and safety teams.

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.

About the Company

MMS

Regulatory compliance and data solutions provider

MMS Holdings is a global contract research organization (CRO) focused on regulatory compliance and data-driven solutions for pharmaceutical and biotech sponsors. It delivers services such as regulatory submissions, clinical trial management, data analytics, and medical writing through a service-based model that relies on established processes and experienced advisors. Its work is contract-based, often long-term, aimed at helping clients meet regulatory requirements, run trials efficiently, and advance therapies under FDA guidance. The company differentiates itself with a science-first approach, a strong track record (97% client satisfaction), and involvement in complex areas like enabling MDMA-assisted therapy research, underscoring a commitment to high-quality, compliant outcomes for sponsors globally.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Canton, Michigan
Founded: 2006

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