Clinical Data Management Specialist (Medical Devices)

TL;DR

Clinical Data Management Specialist (Medical Devices): Leading clinical data management for medical device studies from planning through database lock with an accent on EDC design, data review, query management, reconciliation, and regulatory compliance. Focus on designing clinical databases, resolving complex data discrepancies, coordinating cross-functional study teams, and improving data quality and process efficiency.

Location: Libertyville, Illinois, United States

Salary: $77,000–$120,000 per year

Company

hirify.global is an employee-owned healthcare products company developing, manufacturing, and marketing ostomy, continence care, and critical care products worldwide.

What you will do

• Lead clinical data management activities from study planning through database lock, export, and archiving.
• Develop data management plans, protocol sections, case report forms, edit checks, data dictionaries, and Trial Master File documentation.
• Design and program clinical study databases in EDC systems and lead user acceptance testing.
• Monitor clinical data, manage queries and discrepancies, and coordinate adverse event and device deficiency reconciliation.
• Collaborate with Clinical Affairs, Biostatistics, Clinical Operations, Clinical Science, CROs, EDC vendors, and other stakeholders.
• Identify data trends, report study metrics, and lead process improvement and automation initiatives.

Requirements

• Bachelor’s degree with 2–5 years of related experience, or an equivalent combination of education, training, and work experience.
• At least 2 years of EDC database programming and data monitoring experience.
• At least 2 years of medical device and/or pharmaceutical clinical research experience.
• Experience with EDC systems such as Medrio, Clinpal, or Medidata Rave.
• Understanding of clinical research regulations, Good Clinical Practice, data management processes, questionnaire development, and database structure.
• Proficiency with Microsoft Word, PowerPoint, Excel, and Teams.

Nice to have

• Certified Clinical Data Manager certification through SCDM or a similar organization.
• Knowledge of continence care, critical care, or ostomy products.

Culture & Benefits

• Employee-owned organization focused on making life more rewarding and dignified for people using its products and services.
• Medical, prescription, dental, vision, disability, life, accident, wellness, and spending or savings account benefits.
• 401(k) retirement plan with auto-enrollment, Roth contributions, vesting, and eligible safe-harbor matching contributions.
• Paid holidays, vacation, sick leave, parental and caregiver leave, and statutory leave programs.
• Education assistance, adoption assistance, recognition programs, and potential participation in the Secure Start Bonus Plan.