Safety Trial Manager

Biotechnology and Pharmaceutical Safety Trial Manager Job Description:General Summary:Provides regional and/or global leadership for the management of the all safety monitoring process for particular clinical trials. Assists project team in the design and execution of high quality clinical studies to ensure safety and effectiveness of BSC products. Works under the direction of management on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Interfaces with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO’s. Participates tactically by completing narratives for SAEs and urgent assessment of UADE.Duties and Responsibilities:? Interacts directly as lead Safety representative with project teams, Medical Directors, Safety Trial Managers, MRAs, and Coordinators in order to process and track AEs in accurate, efficient and compliant manner. ? Responsible for the management of dynamic safety processes by tracking adverse events, monitoring timelines for event processing, reviewing safety data at regular intervals, and monitoring adjudication results by the Clinical Events Committee (CEC).? Review source documents and CRF data to independently write event narratives that accurately reflect the adverse event in a clear and concise manner.? Receipt of initial reports and communication with clinical sites and external vendors/core labs to obtain required information for safety reporting ? Tracking documents received, organizing/coordinating medical review of safety narratives and submission of final dossiers to CEC and/or central files? Maintenance of the safety database; compile event metrics for Safety group meetings and monthly report? Assembles dossier(s) for submission to Medical Safety Office for the purpose of regulatory reporting and CEC adjudication Utilize the safety database to generate and maintain safety event reports Display and develop new knowledge in current therapeutic trends and practices by participating in educational opportunities. Assists in the management of the adjudication process Contributes to CRF and protocol design as well as database validation. May be accountable for one or more concurrent clinical studies. May train and mentor Safety Trial Operations staff and Coordinators on safety processes. Participates in and assists in the development and approval of global safety strategies in collaboration with Clinical Sciences management. Reviews instructions for use for investigational devices. Attends project and team meetings representing the Safety group. Provides oversight of safety concerns and/or adverse events to ensure they are identified and appropriate responses to such concerns are developed and executed. Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies. Participates in the dissemination of safety information to the clinical team members and extended core team members, as appropriate. Demonstrates working knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies. Provides clinical support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.Minimum Education & Experience:Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 3-5+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials preferred, Exhibit knowledge regarding current therapeutic trends and practicesWorking Conditions:General office environment, with the potential for up to approximately 30% travel to research laboratory or hospital settings, meetings and other BSC facilities. Potential exposure to blood borne pathogens and other potentially infectious materialsCompetency Expectations:Must be able to think analytically, have the ability to process scientific and medical data,Job Experience:Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 3-5+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials preferred, Exhibit knowledge regarding current therapeutic trends and practicesMinimum Education Required: DoctoralExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.