[Hiring] Senior Medical Monitor @MMS

Role Description

• 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.
• Work 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.

Qualifications

• 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 responsible for timely assessment of clinical trial data and participation in safety surveillance activities for assigned studies in Phase I-III.
• 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.