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The Medical Safety Monitor is responsible for the oversight of the adverse events and product experiences reported within a clinical trial. The Medical Safety Monitor ensures the appropriate reporting of the events to the Clinical Development Department and applicable Regulatory Authorities throughout the life of the trial. The Medical Safety Monitor acts as the liaison between the Safety department and all other internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.
Participates in protocol review for safety input such as requirement of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
· Participates in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
· Assists with all activities related to establishing and managing all safety-related processes.
· Participate in vendor selection for DSMB, CEC and Safety outsourcing activities
· Reviews all safety related data for various clinical trials.
· Reviews clinical safety databases. creating narrative reports for notable clinical events. assisting sites with subject evaluation and protocol adherence. and preparing safety reports to support regulatory notifications and filings.
· Serve as the main liaison between the different bodies involved in the safety process i.e. between the DSMB, CEC, CRO, investigators, and study team.
· Lead safety work in an outsourced model with different safety responsibilities allocated to multiple organizations · Support preparation of periodic safety reports to the FDA and IRB/IECs.
· Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
· Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
· Develop, coordinate and complete clinical study safety training for all staff involved with clinical study.
Will report to the senior manger of safety.
· Is responsible to support the budget goals of the safety department but not directly responsible for budgeting activities.
· Will have internal contact with applicable departments in regards to the activities of the clinical trial(s).
· Will have external contact with applicable committees (e.g., CEC, DSMB & CROs) in regards to the activities of the clinical trial(s).
Bachelors degree or equivalent combination of education and experience. Masters, M.D., PH.D., RN, BSN, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) strongly preferred. Employee must have a strong clinical orientation and knowledge of diverse therapeutic categories. Minimum of 5-7 years of clinical research experience, preferably at least three years in medical safety and one year in medical devices. Direct patient care is strongly preferred. Adequate knowledge in reviewing, interpreting and reporting medical records.
· Adequate knowledge in reviewing and interpreting medical diagnostic tests.
· Excellent verbal and written communication skills · Excellent negotiation and presentation skills
· Knowledge of FDA and ICH
· Regulations/Guidelines governing the reporting of adverse events strongly preferred.
· Experience using relational database applications for clinical trial management and safety management
· Experience in participating in safety review processes.
· Experience in participating in the conduct of clinical trials.
· Familiar with medical terminology and MedDRA
· Organizational skills & ability to direct and manage projects.
· Ability to manage multiple priorities
· Analytical, detail-oriented, and with ability to solve problems and multi-task.