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About the Role

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 high-quality clinical evidence to demonstrate product safety and performance.

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.
Provide 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.
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.
Create clinical trials reports.
Ensure submission package readiness for Ethics Committees approval, including clinical protocols, design case report forms, patient and investigator brochure, and informed consent form.
Verify that data entered on to the CRFs is consistent with patient clinical notes through source data/document verification, collecting completed CRF forms.
Support and review statistical plans for clinical trials.
Monitor updates regarding ethical considerations, scientific principles, legislation, regulatory guidelines, and the clinical evaluation process.
Identify and communicate study-related risks and operational challenges.
Participate in continuous improvement initiatives related to clinical processes.

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.
Knowledge in Medical Device Regulation.
Advanced English C1 scored.
7+ years of experience on similar roles.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.).
Periodic travel in the United States and other regions is required.
A valid passport and full travel availability are essential.

Location

Remote (United States)

Work Type

Remote
Full-time

Experience Level

7+ years

Education Level

Bachelor's degree
Good Clinical Practices certification

About the Company

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.
Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica.
Products are approved for sale in more than 85 countries.
The company trades on the NASDAQ stock exchange under the ticker symbol ESTA with 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.

Equal Opportunity

Establishment Labs is 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.