CQMS Developer

Position: Clinical System Developer - CQMS & eTMF

Overview:

Are you passionate about advancing clinical research technology? We are seeking a Clinical System Developer with hands-on experience in COTS products, specifically CQMS (Clinical Quality Management System) and eTMF (electronic Trial Master File). In this role, you'll leverage your expertise to manage and enhance our clinical systems, ensuring optimal functionality and compliance with regulatory standards. This role is mostly remote, but may occasional require on-site work.

Responsibilities:

• Act as a technical subject matter expert for CQMS and eTMF systems, overseeing their installation, configuration, and ongoing maintenance including custom modifications new development.
• Collaborate closely with project teams to gather requirements, develop documentation for GAMP5 Computer Systems Validation, and support qualification testing.
• Coordinate with vendors and internal teams to ensure the software meets research and regulatory requirements.
• Lead training sessions for internal and external users, including train-the-trainer sessions, and develop comprehensive user reference materials.
• Demonstrate a deep understanding of GxP, ICH guidelines, and regulatory requirements for clinical research and Trial Master Files.
• Establish and maintain processes, work instructions, and other documentation to support the management and optimization of CQMS and eTMF software.

Qualifications:

• 3+ years of experience as a business analyst or clinical system developer, including documentation and workflow diagram creation.
• 1+ years of hands-on experience with CQMS and eTMF systems, including system configuration and maintenance.
• Proficient in delivering effective verbal and written presentations and communications.
• Knowledge of Google Cloud Platform, TMF governing regulations, the TMF Reference Model, GAMP5 for Computer Systems Validation, and 21CFR Part 11.
• Proven ability to build and maintain strong relationships with management, peers, customers, and stakeholders.
• Demonstrated initiative and the ability to work independently.
• Ability to obtain a security clearance.
• Bachelor s degree in a relevant field.

Salary:

$90K-$120K, based on technical skills, work experience, education, certifications, and clearance.

Blu Omega is a Woman-Owned Small Business IT services firm headquartered in Washington, DC, supporting clients nationwide. We offer technology solutions for enterprise and government customers, with a strong track record in Data Management, Cloud/Infrastructure, Software Development, and Enterprise Applications.

What Blu Omega Offers:

• Competitive benefits including Health Insurance, 401K with match, Paid Time Off, and more.
• A results-driven culture that embraces our core values.
• Rewarding work contributing to critical national programs.

Blu Omega is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.