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About the Role
Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer through innovative therapies. We are seeking passionate individuals to join our mission and make a direct impact on improving lives globally. As a people leader, you will be instrumental in fostering an inclusive, developmental, and empowering culture.
Responsibilities
- 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
Requirements
- 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
- 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
Skills
- Clinical Operations
- Clinical Trial Management
- Communication
- Teamwork
- Decision-making
- Organizational skills
- Protocol interpretation
- Task prioritization
- PMDA Regulations
- ICH Guidelines
- GCPs
- SOP development and implementation
- Scientific communication
Experience Level
- 6+ years of experience
Education Level
- BS in a relevant scientific discipline
About the Company
- For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer.
- We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
- We continue to fight against the world’s biggest health challenges.
- 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.