Director IT Site Technology Solutions (1075356)

The Judge Group, INC.; New York (NY); Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative pharmaceutical company is seeking a Director of IT Site Technology Solutions to lead the implementation and management of clinical technologies. This role involves developing processes and policies to ensure high-quality technology integration at clinical sites. You will collaborate with various stakeholders to identify gaps and standardize procedures, ensuring compliance with regulatory requirements. If you are a self-starter with strong project management skills and a passion for technology in clinical operations, this is the perfect opportunity to make a significant impact in a dynamic environment.

Qualifications

• 8+ Jahre Erfahrung in klinischer Technologie oder verwandten Bereichen.
• Starke Projektmanagementfähigkeiten und Anpassungsfähigkeit an verschiedene Zielgruppen.

Responsibilities

• Entwicklung von Prozessen und Verfahren für klinische Technologien.
• Zusammenarbeit mit IT und klinischen Operationen zur Unterstützung der Studieninitiativen.

Skills

Projektplanung

Kommunikationsfähigkeiten

Selbstmotivation

Anpassungsfähigkeit

Wissen über klinische Strategien

Education

BSc/BS/BA in Wissenschaft, Technologie oder Wirtschaft

Tools

Learning Management Systems

Job description

Director, IT Site Technology Solutions

Location:Remote

The Role:As the Director, IT Site Technology Solutions, you will provide subject matter expertise in the implementation and management of site-facing clinical technologies for a pharmaceutical company. Your role will involve developing processes, policies, and procedures for the use of assigned technologies to assist sites participating in clinical studies. You will support site-based sub-projects within overall clinical study initiatives, ensuring efficient, consistent, and high-quality implementation of site technologies with minimal regulatory risk.

Key Responsibilities:

• Identify process area gaps, source stakeholder input, and develop and maintain process tools.
• Support the implementation of site technology solutions and activities.
• Standardize elements of site feasibility and selection, IRB/IBC approvals, document collection and distribution, training, patient recruitment, and enrollment.
• Collaborate with Information Technology and Clinical Operations to address specific needs for site selection, study start-up, patient enrollment, safety letter distribution, study conduct, and study closure.
• Serve as a support resource to Information Technology and Clinical Operations colleagues.
• Oversee vendor activities related to Digital Solutions, including Learning Management Systems, patient enrollment, TMF, and essential document collection.
• Maintain scope of outsourced work, including work instructions, task ownership matrices, escalation paths, and SLAs for vendors.
• Develop oversight plans and metrics for outsourced services.
• Lead change management efforts for new systems or process improvements.

Requirements:

• Degree in a scientific, technology, and/or business discipline, with 8+ years of experience with a BSc/BS/BA degree.
• Prior clinical technology experience is a plus.
• Experience in supporting, planning, and overseeing site-facing clinical trial technologies and vendors.
• Firm understanding of GDPR requirements.
• Strong project planning and management skills.
• Excellent written and verbal communication skills, adaptable to various audiences.
• Ability to understand clinical strategy and its impact on site-based technologies.
• General understanding of computer systems lifecycles and the clinical trial process.
• Team player with strong communication skills and the ability to self-motivate.
• Self-starter with original thinking and the ability to work independently.
• Adaptable to working with study teams with varying levels of technical experience.
• Knowledge of current technology trends and their application to clinical operations.
• Ability to stay current with regulatory and technical trends impacting site-facing technology implementation.