Übersicht Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Verantwortungsbereiche This remote-based EU Clinical Safety Specialist monitors all safety aspects of our clinical research trial(s). With guidance, the Clinical Safety Specialist is responsible for collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB across our clinical studies to ensure compliance with regulations and guidelines.

Key Responsibilities

• Execution of Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB):
• Adheres to the study protocols and charters.
• Provides reports and statistics related to dissemination of safety information to the clinical trial management team members and clinical trial core team members, as appropriate.
• Monitors timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjudication results.
• Initiate missing data queries/data clarification queries to clinical sites regarding adverse events.
• Requests appropriate source documentation necessary to analyze adverse events for seriousness and causality.
• Prepares narratives of adverse events for adjudication by the CEC.
• Participates in the preparation, attendance and hosting of CEC and DSMB meetings, providing agenda, recording/reviewing and distributing of minutes to key stakeholders internally and externally including CEC/DSMB Chair
• Collects, reviews and files all clinical study documentation/correspondence and maintains the clinical trial master file (TMF).
• Synthesizes information from various sources as it pertains to the safety of all patients enrolled in a study in accordance with study protocols and compliance with governmental/health authority regulations.

Safety Surveillance and Reporting

• Assists with reporting adverse events (individual or summary reports), and any other activity in keeping with the defined endpoints of the trial charters.
• Reviews adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.
• Collaborate with Data Management and contribute to the cleaning of data.
• Reports safety findings in a summary internally.
• Contribute to the coding of events according to MedDRA or IMDRF standards.
• Interfaces with project management, functional team members and investigators to ensure a timely and precise safety reporting process.
• Assists in preparing clinical study reports of assigned projects for submission to regulatory authorities.

Personal Health Information / GDPR compliance

• Contribute to the monitoring and reporting of personal data breaches that may be identified in the course of clinical investigations (e.g. source documentation).

Strategic Impact

• Supports clinical safety management for all sponsored clinical studies, with an initial focus on drug-eluting balloon catheters.

Key Interactions

• Supervisor: Director of Global Clinical Safety
• Internal Interactions: This role will interact heavily with clinical teammates across projects
• External Customer Interactions: This role will be working with DSMB and CEC members, Clinical trial physicians and research coordinators, contract research organizations, core labs, etc.

Qualifikationen Required Experience

• Bachelor’s degree
• Minimum of 3 years of experience in medical device clinical studies
• Experience with safety reporting, guidelines, compliance and oversight across US and EU regions, pre-market and post-market
• Cardiovascular experience

Competencies & Skills

• Precise, rigorous, detail-oriented with strong work ethic
• Excellent communication, writing and listening skills
• Fluent in English
• Professionalism and ability to effectively interact with peers and management alike
• Ability to verbally communicate effectively with management, department clinical research and other team members

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