Clinical Data Manager (Medtech)

Location: US; Plymouth, MN (Remote). Travel up to 10% may be required, including day trips, overnight stays, and visits to local sites or meetings.

Salary: USD 105,000–130,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive histotripsy therapy platform for liver tumors and future applications across multiple disease areas.

What you will do

• Define appropriate data elements with stakeholders during CRF development and manage CRFs for pre- and post-market clinical studies.
• Liaise with database vendors on database development, CRF implementation, specifications, and feedback.
• Perform and improve User Acceptance Testing for new and updated clinical databases.
• Draft Data Management Plans and Data Review Plans, and manage data queries and data quality throughout trials.
• Collaborate with Data Science on statistical analysis processes and develop clinical metrics for internal and external use.
• Manage timely data locks for reporting and regulatory submissions and assist with internal and external audits.

Requirements

• Bachelor's degree in a scientific discipline.
• At least 5 years of medical device clinical study experience.
• Knowledge and experience with GCP, ICH, GDPR, and FDA/EU regulatory environments.
• Understanding of clinical data management standards for medical devices.
• Expertise in developing, validating, and managing clinical study databases across CRF design, database development and testing, discrepancy management, data quality review, data analysis, and final database archival.
• Excellent written and verbal communication, analytical, critical-thinking, problem-solving, collaboration, leadership, and relationship-management skills.
• Ability to prioritize multiple tasks and deadlines, maintain communication during shifting priorities, and convert strategic plans into operational objectives.
• Proficiency in Microsoft Office, including Word and PowerPoint.
• Ability to lift 20 pounds and view a computer screen for 8 hours per day.
• Must be willing and able to travel up to 10% of the time.

Nice to have

• Pre-market experience with medical device clinical data management standards.
• Experience as a CRA or developing, validating, or administering clinical systems for data collection or clinical data analysis.

Culture & Benefits

• Full-time employment with health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k), paid time off, and additional benefits.
• Work may be performed remotely, with possible on-site office work and exposure to electrical office equipment.
• Equal opportunity workplace that values diversity.