Clinical Trial Principal (Remote - US)

Establishment Labs•Austin, TX

1d•Remote

About The Position

Establishment Labs is a rapidly growing medical device company focused on women's health, aesthetics, and reconstruction. We are seeking a Clinical Trial Lead to manage and execute clinical investigations in compliance with international regulations and company procedures. This role ensures studies adhere to Good Clinical Practice (GCP), ISO 14155, and regulatory requirements, meeting timelines and quality standards. The Clinical Trial Principal will provide leadership throughout the clinical trial lifecycle, coordinate cross-functional teams, support regulatory submissions, and ensure the generation of high-quality clinical evidence for product safety and performance. This is a remote role open to candidates across the United States.

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
Knowledge of Zotero/Mendeley
Knowledge of 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.
A valid passport and full travel availability are essential.

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 product registration and technical file (Clinical Evaluation Report).
Oversee clinical trial operations and site performance.
Create clinical trials reports.
Prepare submission packages for Ethics Committees approval, including clinical protocols, design case report forms, patient and investigator brochures, and informed consent forms.
Verify that data entered on to the CRFs is consistent with patient clinical notes (source data/document verification) and collect 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.