Clinical Data Coordinator (Medical Device) - Intellectt INC

Role: Clinical Data Coordinator (Medical Device)

Location: Maple Grove, MN

Duration: 6 Months on W2 (Possible Extension)

Onsite: 100% On-Site

Job Summary:

• The Clinical Data Coordinator supports data management activities for clinical studies to ensure high-quality data for regulatory submissions, safety monitoring, and publications. This role ensures compliance with Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and FDA regulations.

Key Responsibilities:

• Manage data for assigned studies: Case Report Form (CRF) development, Edit Check specifications, Data Management Plans, data quality checks, and discrepancy management.
• Analyze data and identify trends; prepare clinical data tables.
• Test and verify clinical data management systems and edit check programming.
• External data handling, device reconciliation, and post-market surveillance reporting.
• Ensure timely completion of data management tasks or escalate issues as needed.
• Participate in study team meetings and collaborate with internal teams.
• Ensure compliance with regulatory standards (FDA, ICH, ISO 14155) and internal SOPs and guidelines.
• Continuously improve processes and maintain positive relationships with employees and customers.
• Identify and resolve data issues in a highly repetitive work environment.

Required Skills:

• 2 years of experience in clinical data management or related clinical research environment (1 year considered if other requirements are met).
• Strong communication (written and verbal), organizational skills, attention to detail, and ability to manage multiple projects.
• Strong computer skills, including intermediate-level Excel skills (pivot tables, search functions, x-lookups).
• Knowledge of Oracle Clinical Database preferred but not required.
• Continuous improvement mindset and willingness to work occasional overtime.

Education:

• High school diploma or GED required.
• College graduates with at least one year of experience will be considered.