Jake D. Mason

About Jake D. Mason

Specialties: IxRS/IRT, ePRO/eCOA, EDC, eTMF, CTMS, drug management systems, drug Safety systems, help desk management, help desk support, and overall clinical systems management

Experience

1. Irt Consultant

   Converge Consulting

   May 2025 — Present

   Oversee the IRT design and implementation from user requirement specifications through Go-Live, ensuring alignment with the clinical study protocol• Participate in client meetings, design sessions, and sandbox testing• Manage project plans to ensure timely completion of UAT scripts, incorporating key milestones and activity timelines• Communicate IRT implementation project status, accomplishments, risks, and issues to stakeholders• Identify, escalate, and drive resolution of project related challenges• Support computer system validation activities• Develop IRT UAT scripts, EDC integration support, and provide live UAT support• Manage system enhancements and ongoing configuration adjustments• Manage daily issue resolution

Education

• California State University, Fresno

  Bachelor of Science (B.S.), Health Science

  1997 — 2002

Skills

• Ctms
• Edc
• Clinical Trials
• Gcp
• Oncology
• Clinical Development
• Clinical Research
• Clinical Data Management
• CRO
• 21 Cfr Part 11
• Biotechnology
• Pharmaceutical Industry
• Sop
• Ixrs
• Ivrs
• Iwrs
• Cross-Functional Team Leadership
• Clinical Study Design
• Clinical Monitoring
• Oracle Clinical
• Drug Development
• Standard Operating Procedure (Sop)
• Electronic Data Capture (Edc)
• Clinical Trial Management System (Ctms)
• CRO Management
• Protocol