CDISC Specialist, Pinnacle 21 Japan

Summary Description
Pinnacle 21 is a Philadelphia-based, established clinical technology industry leader in software and services for managing clinical trial data standards compliance, clinical data quality, and health authority submission readiness. Pinnacle 21 works with the PMDA, FDA, and global pharmaceutical sponsors and clinical research organizations to implement and support a go-to platform to validate clinical data in effort to help revolutionize the speed and efficiency of the Review Process. We are focused on ensuring continued compliance and data fitness for our clients.

As we focus on continuing to expand our user base in that region, you’ll be tasked with representing our mission and value to the Japanese clinical market. The CDISC Specialist will manage and coordinate a broad range of activities in assistance of our Japanese Country Manager. These activities include engaging with our expanding Japanese customer base, supporting Japanese business development activities, gathering product
feedback/requirements, and serving as a liaison to the Japanese health authority.

Detailed Description
• Establish strategic relationships with users, stakeholders, and partners
• Provide product feedback and requirements from Japanese client base to Product Management team
• Provide first-tier support for Japanese speaking clients and help communicate information to Pinnacle 21 Support
• Participate/present at conferences, user groups, webinars, thought leadership and other presentations as a Pinnacle 21 representative
• Support business development activities across Japan and other Asian markets
• Work in close coordination with home office departments (Engineering, Product Management, Customer Success, etc) to ensure products meet Japanese market demands

Must

• 4+ years of experience within clinical statistical programming
• Have ability to prepare and manage SDTM and ADaM datasets
• Knowledge and experience within network protocols, software, and hardware involved in cloud networking configuration and management
• Be bilingual in Japanese and English
• Excellent project management and leadership skills
• Anticipate and resolve issues independently with the understanding of when to seek assistance
• Strong attention to detail, organization and time management skills
• Ability to work as a team player with multi-disciplinary project teams

Plus

• Be able to travel internationally and to client sites

Location
Tokyo, Japan