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 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.
