Clinical Trial Lead – Medical Device Research

About the role

Establishment Labs is seeking a Clinical Trial Lead to drive the design, execution, and delivery of clinical investigations for its innovative women’s health medical devices. You will ensure studies comply with international regulations and generate high‑quality evidence of safety and performance.

Key responsibilities

• Coordinate and oversee all phases of clinical trials, from protocol development to site management.
• Mentor junior staff and provide strategic guidance to cross‑functional teams.
• Prepare and maintain trial documentation, including protocols, case report forms, informed consent, and clinical evaluation reports.
• Support regulatory submissions by supplying clinical data and technical files.
• Verify source data against CRFs and ensure data integrity.
• Monitor ethical, scientific, and regulatory updates and communicate risks.
• Participate in continuous improvement initiatives for clinical processes.

Required profile

• Proven experience leading clinical investigations for medical devices.
• Strong knowledge of GCP, ISO 14155, and relevant regulatory frameworks.
• Ability to manage multiple studies simultaneously and meet timelines.
• Excellent communication skills for interaction with ethics committees, investigators, and internal stakeholders.

Required skills

• Good Clinical Practice (GCP) compliance
• ISO 14155 standards
• Clinical trial management
• Regulatory submission preparation
• Statistical analysis of trial data
• Clinical documentation creation
• CRF data verification

What we offer

• Opportunity to shape groundbreaking women’s health technologies.
• Dynamic, fast‑growing international environment.
• Access to state‑of‑the‑art manufacturing facilities.