About this role
About Us:
Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.
Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.
Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.
This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.
Objective
The Clinical Data and Systems Specialist is responsible for supporting global clinical studies through the management of clinical data, clinical systems, and related operational processes across the entire study lifecycle. This role ensures that study data is accurate, complete, compliant, and readily available for analysis, reporting, and regulatory purposes while maintaining the highest standards of data integrity and Good Clinical Practice (GCP).
Working closely with Clinical Operations, Biostatistics, Regulatory Affairs, Quality, IT, CROs, and external vendors, this position serves as a key contributor to both clinical data execution and continuous improvement initiatives. The Clinical Data and Systems Specialist helps optimize processes, enhance reporting capabilities, support clinical technologies, and identify opportunities for automation and digital transformation, ultimately enabling efficient, scalable, and data-driven clinical study operations.
Main Responsibilities
• Manage clinical data activities from study start-up through database lock and study closeout.
• Review, clean, and validate clinical data while managing queries and ensuring data integrity.
• Support data entry, quality control processes, and controlled data workflows.
• Perform reconciliations between EDC/CDMS platforms and external data sources, including laboratories, imaging, ePRO/eCOA, devices, and vendors.
• Support clinical systems setup, user access management, User Acceptance Testing (UAT), validation activities, and compliance requirements.
• Maintain study documentation, trackers, action logs, deliverables, and supporting evidence to ensure traceability and inspection readiness.
• Generate reports, dashboards, listings, metrics, and data outputs to support study oversight and decision-making.
• Collaborate with cross-functional teams and external partners to resolve data and system-related issues.
• Identify opportunities for process improvement, automation, and technology-enabled solutions.
• Contribute to the development of standards, templates, training materials, and continuous improvement initiatives within the Clinical Data and Systems function.
Requirements
• Bachelor's degree in Life Sciences, Health Sciences, Biomedical Engineering, Statistics, Data Science, Computer Science, or a related field.
• 2-4 years of experience in clinical data management, clinical systems, clinical research, or regulated data environments.
• Good Clinical Practice (GCP) certification (may be completed during onboarding).
• Strong Excel skills and experience working with structured data, reporting, data quality review, query management, and reconciliation activities.
• Familiarity with CRFs/eCRFs, clinical data workflows, and regulated documentation practices.
• Advanced English (C1 level or equivalent) and fluent Spanish.
• Strong analytical, organizational, problem-solving, and communication skills, with the ability to collaborate effectively across cross-functional teams.
• Experience working with EDC/CDMS platforms and external clinical data systems is preferred.
• Knowledge of Power Query, Python, Tableau, Power BI, SQL, R, SAS, or similar analytics and reporting tools is preferred.
• Experience supporting UAT, system validation, access management, and compliance activities is preferred.
• Knowledge of CDISC, CDASH, ICH-GCP, 21 CFR Part 11, and risk-based validation principles is preferred.
• Experience within CRO, medical device, pharmaceutical, sponsor, or regulated clinical research environments is preferred.
• Master's degree or additional studies in Clinical Research, Data Science, Biomedical Informatics, Regulatory Affairs, or related fields is preferred.
• SCDM certification, clinical data management training, or related certifications are preferred.
Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.
At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.