Clinical Data & Systems Specialist

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.

About the Role:

The Clinical Data & Systems Specialist is responsible for the end-to-end management of clinical data for clinical studies. This role requires strong expertise in data review, data cleaning, and data reconciliation, as well as hands-on experience with EDC/eClinical platforms and the full study lifecycle, from study startup through database lock and closeout.

The ideal candidate can work independently in a regulated environment, identify risks, and propose effective solutions, while collaborating efficiently with cross-functional teams and external vendors. Advanced analytical skills, strong proficiency in Excel, and knowledge of tools such as Python, R, or SQL are highly valued.

Main responsibilities:

• Extensive experience in data review and cleaning, query management, data reconciliation, and ensuring inspection-ready data for regulatory audits and inspections.
• Hands-on experience with EDC/eClinical systems, including study builds, change management, User Acceptance Testing (UAT), validation, and system releases.
• Ability to work independently in regulated environments, proactively identifying risks, priorities, and solutions.
• Excellent collaboration skills, working effectively with Clinical Affairs, Regulatory Affairs, Quality, IT, CROs, and external vendors, supported by well-developed interpersonal skills.
• Strong analytical skills, including advanced Excel proficiency. Experience with Python, R, SQL, or data automation tools is considered an advantage.

Requirements:

• Bachelor's or Licentiate degree in Life Sciences, Health Sciences, Biomedical Engineering, Statistics, Data Science, Computer Science or a related field.
  
• With more than 4 years of hands-on experience supporting clinical studies at a sponsor, CRO, or research organization.
• Advanced English C1 (speaking and reading).
  
• Advanced analytical skills, including Excel; experience with Python, R, SQL, or data automation tools is a plus.

Soft skills:

• Curious
• Detail-oriented
• Critical thinking
• Organizational and prioritization skills
• Adaptability and change management
• Ability to identify and mitigate risks
• Scientifically minded
• Genuinely motivated to improve processes, standards, automation, and team capabilities

Test to the process:

• Interview with Talent Acquisition
• English Assessment
• Assessment center Evaluation
• Competency-based interview with the Hiring Manager and Team

The shift for this position is Monday through Friday, from 8:00 a.m. to 5:00 p.m. (Hybrid role)

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.