Clinical Trial Principal (Remote - US)
About Us: Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company. Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries. Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion. This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry. Please note this is a remote role, we will be considering roles from around the United States. Objective The Clinical Trial Lead is responsible for the execution, oversight, and successful delivery of clinical investigations in compliance with applicable international regulations and company procedures. The role ensures clinical studies are conducted according to Good Clinical Practice (GCP), ISO 14155, and regulatory requirements while meeting timelines, quality standards, and project objectives. The Clinical Trial Principal provides operational and scientific leadership throughout the clinical trial lifecycle, coordinating cross-functional teams, supporting regulatory submissions, and ensuring generation of highquality clinical evidence to demonstrate product safety and performance. Main Responsibilities Coordinate and oversee clinical trial activities throughout the study lifecycle. Provide strategic guidance and oversight, mentoring junior staff and coordinating with management. Develop and maintain clinical trial documentation. Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials. Create, implement and administer methods and procedures to enhance operations, as appropriate. Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report). Oversee clinical trial operations and site performance. Clinical trials reports creation. Submission package readiness for Ethics Committees approval; including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others. Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification, collecting completed CRF forms. Support and review of statistical plans for clinical trials Monitor any updates that may arise about ethical considerations, scientific principles, legislation and regulatory guidelines, and clinical evaluation process. Identify and communicate studyrelated risks and operational challenges Participate in continuous improvement initiatives related to clinical processes. Technical Requirements: Bachelor’s degree in a relevant field such as life sciences, engineering, pharmacy, business, clinical research, or a related discipline. Good Clinical Practices certification Knowledge in Systematic literature search Zotero/Mendeley Medical Device Regulation Advanced English C1 scored 7+ years of experience on similar roles Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.) This role requires periodic travel in the United States and other regions. A valid passport and full travel availability are essential. Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions. At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.