Job role: Senior Clinical Data Coordinator
Experience: 5 yrs
Location: Maple Grove, MN
Role Summary
The Senior Clinical Data Coordinator performs clinical data management activities across the study lifecycle to ensure the integrity, completeness, and quality of data in clinical databases and study files. Working under limited supervision, this role manages assigned studies, identifies and resolves data issues, supports study teams and sites, and helps improve clinical data management practices and procedures.
Key Responsibilities
• Supports testing and verification of clinical data management systems (CDMS).
• Manages data discrepancies by creating, routing, tracking, and resolving queries.
• Reviews clinical data forms, listings, and reports to identify inconsistencies and maintain database integrity.
• Supports reconciliation of data from multiple sources, including core laboratory and device data.
• Responds to site data needs, including support requests, patient transfers, and site closures.
• Performs data entry and quality control review for data received in paper or equivalent formats.
• Maintains accurate study metadata, including site, subject, and study personnel information.
• Provides administrative study support, including scanning, copying, redacting, filing, and related activities.
• Identifies root causes of data issues, facilitates resolution, and recommends preventive process improvements.
• Supports development and implementation of clinical data management practices, SOPs, and work instructions.
• Complies with FDA regulations, other applicable requirements, company policies, and operating procedures.
• Maintains effective, collaborative communication with employees, customers, contractors, vendors, and study partners.
Required Qualifications
• High school diploma or GED with specialized training or related experience, or an equivalent combination of education and work experience.
• Minimum 5 years of experience as a Clinical Data Coordinator or in a comparable clinical research environment with direct exposure to data management processes.
• Experience with clinical data management systems, such as Oracle Clinical.
• Strong organizational skills, attention to detail, and ability to perform recurring tasks with a high degree of accuracy.
• Ability to manage multiple studies, projects, priorities, and timelines under limited supervision.
• Strong written and verbal communication skills with the ability to work effectively across organizational levels.
• Ability to work independently and collaboratively in a fast-paced, changing environment while handling sensitive information with discretion.
• Proficiency with Microsoft Word, Excel, Outlook, Adobe, and related business applications.
• Ability to maintain regular attendance, work at a computer for extended periods, and support occasional overtime as required.
Preferred Qualifications
• Experience reconciling clinical data from core laboratories, medical devices, or other external data sources.
• Experience improving or implementing clinical data management practices, SOPs, or work instructions.
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