Clinical Trials Manager

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Responsibilities

The position is responsible for managing Japan portion of all phases 1-4 clinical trials for various therapeutic areas in partnership with global/regional clinical operations team and other functions under supervision of Clinical Program Manager/Associate Director of Japan Clinical Operation. Coordinating and supervising all aspects of a clinical study Monitoring clinical trial sites Assisting study teams in overall study management Managing CROs/vendors Maintaining study timelines Contributing to study budgets Coordinating protocol/ICF/CRF reviews Coordinating clinical study reports Training investigators/CROs/vendors Supporting scientific communications Supporting project priorities Domestic and international travel

Basic Qualifications

BS in a relevant scientific discipline

• 6+ years of experience in Clinical Operations as a core Study Team member or Clinical Trial Lead Good communication skills in Japanese and English (TOEIC L&R 750+, IELTS 6.0, CEFR B2)
• Must meet all requirements for Senior Clinical Research Associate position and have demonstrated proficiency in all relevant areas
• Excellent teamwork, communication, decision-making, and organizational skills
• Must be able to understand, interpret, and explain protocol requirements
• Must be able to prioritize multiple tasks

Preferred Qualifications

Thorough knowledge of PMDA Regulations, ICH Guidelines, and GCPs governing clinical trials

• Ability to examine functional issues from an organizational perspective
• Ability to participate in departmental and cross-functional strategic initiatives Functional expertise to support SOP development and implementation
• Ability to serve as a resource for clinical trial management expertise within the organization For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.