Clinical Data Coordinator - Intellectt INC

Job Title: Clinical Data Coordinator
Location: Maple Grove, MN
Duration: 4+ months
100% onsite role

Job Summary: Responsible for overseeing data management activities for assigned clinical studies to ensure high-quality data for regulatory submissions, safety monitoring, and publications. Follows Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP). Uses effective and efficient processes and ensures the quality of services meets internal and external standards.

Key Responsibilities:

• Develop and maintain Case Report Forms (CRF) and Edit Check specifications.
• Create and update Data Management Plans.
• Conduct data quality checks and manage discrepancies.
• Analyze data, identify trends, and prepare data tables for clinical reports.
• Test database setups and Edit Check programming.
• Manage external data and participate in device reconciliation.
• Contribute to Post Market Surveillance reporting as needed.
• Ensure timely, high-quality completion of data management tasks or escalate issues when necessary.
• Collaborate with study teams and represent Data Management in team meetings.
• Stay updated on clinical trial regulations and SJM devices.

Requirements:

• Familiarity with clinical trial processes and applicable regulations (FDA, ICH, ISO 14155).
• Ability to follow departmental SOPs, work instructions, and guidelines.
• Strong communication skills and ability to work across all levels of employees.

Other Duties:

• Support company initiatives related to Quality and Environmental Management Systems.
• Perform additional tasks as assigned.