5+ years of medical monitoring or clinical research experience.
Proficient in protocol amendments and informed consent form (ICF) updates.
Strong understanding of clinical data and aggregate data review.
Excellent knowledge of regulatory guidelines (ICH, FDA, EMA).
Exceptional scientific writing and communication skills.
Proficient in MS Office applications.
Responsibilities
Provide medical oversight for clinical trials and observational studies.
Review participant eligibility and safety-related clinical data.
Support development of clinical study documents and protocols.
Respond to safety inquiries and provide medical guidance during studies.
Participate in safety and data monitoring committees.
Lead safety activities and aggregate case analysis for assigned products.
Guide regulatory reporting and preparation of safety-related documents.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to lead safety activities on innovative products.
Engagement in high-impact clinical research.
Access to ongoing professional development and training.
Involvement in regulatory strategy and submissions.
Full Job Description
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.
