Clinical Data & Systems Sr. Specialist

About the role

Establishment Labs designs, develops and manufactures medical aesthetic devices and wellness solutions, with production at two MDSAP-certified, carbon-neutral, LEED Gold facilities in Costa Rica. The Clinical Data & Systems Specialist manages clinical data end-to-end for clinical studies, from study startup through database lock and closeout. The role suits someone who can work independently in a regulated environment, identify risks and collaborate with cross-functional teams and external vendors.

Key responsibilities

• Data review and cleaning, query management and data reconciliation, ensuring inspection-ready data for regulatory audits and inspections
• Hands-on work with EDC/eClinical systems, including study builds, change management, UAT, validation and system releases
• Working independently in regulated environments, identifying risks and proposing solutions
• Collaborating with Clinical Affairs, Regulatory Affairs, Quality, IT, CROs and external vendors

Required profile

• Bachelor's or licentiate degree in Life Sciences, Health Sciences, Biomedical Engineering, Statistics, Data Science, Computer Science or a related field
• More than 4 years of hands-on experience supporting clinical studies at a sponsor, CRO or research organization
• Advanced English (C1, speaking and reading)
• Curiosity, attention to detail, critical thinking, organizational skills, adaptability and risk awareness

Required skills

• Advanced Excel
• Experience with Python, R, SQL or data automation tools is a plus
• EDC/eClinical systems

The schedule is Monday to Friday, 8:00 a.m. to 5:00 p.m., in a hybrid arrangement. Selection involves an interview with Talent Acquisition, an English assessment, an assessment center evaluation and a competency-based interview with the hiring manager and team.