Specialist Clinical Data Management (MedTech)

TL;DR

Specialist Clinical Data Management (MedTech): Leading all aspects of clinical data management for medical device products, from study planning to database lock with an accent on EDC design and data quality. Focus on designing clinical study databases, performing UAT, and ensuring regulatory compliance with GCP standards.

Location: Must be based in Libertyville, IL, US

Salary: $77,000 - $120,000 yearly

Company

Independent, employee-owned company specializing in innovative healthcare products for ostomy, continence, and critical care.

What you will do

• Lead clinical data management from study planning to database lock, including EDC design and data cleaning.
• Develop data management plans, Case Report Forms (CRFs), and essential TMF documentation.
• Design and program clinical study databases, including edit checks and data dictionaries.
• Conduct User Acceptance Testing (UAT) to validate build specifications.
• Monitor clinical data, resolve queries, and coordinate AE/DD reconciliation.
• Ensure all activities comply with Good Clinical Practice (GCP) and internal SOPs.

Requirements

• Bachelor's degree with 2-5 years of related experience.
• Location: Must be based in Libertyville, IL, US.
• Minimum 2 years of EDC database programming and data monitoring experience.
• Experience in medical device and/or pharmaceutical clinical research.
• Proficiency with EDC Systems (e.g., Medrio, Clinpal, Medidata Rave).
• Strong understanding of clinical research regulations.

Nice to have

• Certified Clinical Data Manager (CCDM) certification.
• Knowledge of continence, critical, or ostomy care.

Culture & Benefits

• Competitive base pay and secure start bonus plan.
• Comprehensive health, dental, vision, and wellness programs.
• 401(k) retirement plan with safe harbor matching.
• Paid time off including 11 holidays, vacation, and sick days.
• Education and adoption assistance programs.