Senior Medical Monitor (Remote - US)

MMS Holdings Inc; Seattle (WA); Remoto; USD 140.000 - 200.000; Tempo pieno

Descrizione del lavoro

MMS Holdings Inc in Seattle seeks a Medical Monitor to provide oversight for Phase I-IV trials and observational studies. You will review safety data, assess eligibility, and support regulatory submissions while collaborating with cross-functional teams.

Ideal candidates have a MD/DO, 5+ years of medical monitoring experience, and strong knowledge of ICH, FDA, and EMA guidelines. Proficiency in MS Office and data interpretation is required, with excellent written and verbal communication.

Competenze

• MD/DO or international equivalent required.
• 5+ years medical monitoring experience.
• Experience with protocol amendments and ICF updates.
• Strong knowledge of ICH, FDA, EMA guidelines.
• Excellent written and verbal communication skills.

Mansioni

• Provide medical oversight for Phase I-IV trials and observational studies.
• Review participant eligibility, adverse events, lab data and vital signs.
• Support development documents such as Safety Plans and Medical Monitoring Plans.
• Respond to safety inquiries and provide medical guidance throughout studies.
• Lead safety activities and coordinate with cross-functional teams.

Conoscenze

Medical monitoring

Regulatory knowledge

Clinical data review

Medical writing

Communication skills

Formazione

MD/DO or international equivalent

Strumenti

MS Office

Descrizione del lavoro

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 inthecompany.


• 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 reportsummary 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+ yearsof 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.