Clinical Data & Systems Senior Specialist

About the role

Establishment Labs designs, develops and manufactures medical aesthetic devices and wellness solutions, and is looking for a Clinical Data & Systems Senior Specialist. The role manages clinical data end to end for clinical studies, covering data review, cleaning and reconciliation, and the full study lifecycle from startup through database lock and closeout. The position is hybrid, Monday to Friday, 8:00 a.m. to 5:00 p.m.

Key responsibilities

• Review and clean data, manage queries and reconcile data so that datasets are inspection-ready for regulatory audits and inspections
• Work hands-on with EDC/eClinical systems, including study builds, change management, UAT, validation and system releases
• Identify risks in regulated environments and propose effective solutions
• Collaborate 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)
• Curious, detail-oriented, critical thinker with organizational and prioritization skills, adaptable and able to mitigate risks

Required skills

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

The selection process includes an interview with Talent Acquisition, an English assessment, an assessment centre evaluation and a competency-based interview with the hiring manager and team.