Clinical Trial Principal (Remote - US)
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 Principal to lead and oversee clinical investigations. This is a remote role based in the United States. The ideal candidate will ensure studies comply with international regulations and company procedures, meeting timelines and quality standards. This role provides leadership throughout the clinical trial lifecycle, coordinating teams, supporting regulatory submissions, and generating evidence for 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, 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 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.
- Medical Device Regulation.
- Advanced English C1 scored.
- 7+ years of experience on similar roles.
- 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.