Senior Clinical Data Coordinator - C

Title: Senior Clinical Data Coordinator

Location: Pleasanton, California (100% Onsite)

Duration: 6+ Months

Shift Time: 8am to 5pm

Pay Range: $40/hr to $44/hr (On W2)

We are looking for a Senior Clinical Data Coordinator to join one of our Fortune 500 clients.

• Supporting Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complying with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Clinical Data Coordinator experience or experience in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
• Strong skills with MS Office applications, specifically Excel, Word, and PowerPoint are required. Advanced organizational skills, attentiveness to detail, ability to work under limited supervision, and ability to handle multiple projects simultaneously.
• Ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential.
• Must have comprehensive interpersonal skills, including the ability to listen, resolve relatively complex problems, and deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators.
• Must be able to use discretion and handle sensitive/confidential information appropriately.
• Occasional overtime is a requirement of this position.
• Bachelor's degree (preferred) or an equivalent combination of education and work experience required.
• Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to Clinical Data Management and to the clinical trial process.
• Experience using Concur for payments is preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.