Clinical Trial Safety Associate

Job Description WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure
, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team – it’s a great time to join Endotronix!

The Clinical Trial Safety Associate, member of the clinical operations team, will primarily be responsible for ensuring the safety and effectiveness of our medical devices. This includes monitoring and reporting on device performance, managing any safety concerns, and working closely with clinical operations to ensure the highest standards of care for our patients. Your responsibilities will include:

• Review and evaluate adverse event reports (AERs) to determine if they meet regulatory reporting requirements.
• Review clinical narratives
• Communicate with Safety Department of the CRO and other stakeholders to gather additional information about adverse events
• Assist in the preparation of reports for regulatory submissions related to device safety
• Monitor safety literature to stay current on the latest safety information related to the company's products
• Collaborate with other departments such as Clinical Science, R&D, Regulatory Affairs, to ensure compliance with safety regulations and guidelines
• Participate in the development and implementation of safety guidelines and procedures
• Participate in the development and execution of risk management plans

• 2+ years' experience in the device, biotechnical and/or pharmaceutical industry monitoring and managing safety for clinical trials. Device experience preferred, or safety management in a biotech/startup and/ or CRO environment
• Knowledge and an understanding of regulatory guidelines / requirements related to clinical trial implementation of Medical Devices (21 CFR 820, 803, ISO 13485, euMDR 2017/745, safety reporting)
• Previous experience with medical device clinical trial case reporting (Serious Adverse Event (SAE) reports, Device Deficiency (DD) reports etc.) is preferred
• Strong scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety)
• Background in medical device trending/sign detection and heavy statistical analysis experience.
• Able to develop and administer management information systems for tracking and trending.
• Strong analytical and technical skills that include data collection, analysis and required report generation
• Strong communication skills
• Ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within Endotronix.
• Proficient in Data Analysis, Research, Data Automation
• Knowledge of electronic databases (e.g., Argus or other database tools)
• Ability to effectively interact with and influence others without direct reporting relationships
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
• Effectively manage time, multi-task, and handle a high volume of work in a fast-paced environment.
• Advanced proficiency in Microsoft Office Suite (e.g., Word, Excel, PowerPoint, and Outlook).

• Associate degree or bachelor's degree preferred in bio-medical engineering, clinical research, medical technology or other life sciences

• Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
• Someone with a bias for action and quick iteration as opposed to perfection
• A quick learner, who is able to work independently, multitask, and drive your own projects
• An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose‑built…