Job Description

For Current Gilead Employees and Contractors:

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This position

The position is responsible for execution of all phase 1-4 clinical trials, across all therapeutic areas, in Asia Pacific region in partnership with global/regional clinical operations team and other relevant functions, reporting to the Senior Clinical Trials Manager for, Clinical Operations.



Essential Duties and Job Functions

• Partners with Clinical Trials Manager to manages geographical region(s) of a large complex clinical trial and independently manages all components of a small less complex study and phase 1 studies
• Manages vendors and maintains cross functional study timelines in partnership with global study team
• Works with study team and CRO to troubleshoot country/site specific operational issues
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, study plans, investigator brochures and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Coordinates review of data listings and preparation of interim/final clinical study reports
• May be asked to train CROs, vendors, investigators and study coordinators on study requirements
• Establishes good relationship with key institutions and key opinion leaders (KOLs) in the region
• Conducts co-monitoring/oversight and relationship building visits in the region as required
• Contributes to development of study budget and ensures effectiveness of site budget/contract process in the region
• Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
• Participates in departmental, or interdepartmental, strategic initiatives under general supervision

Requirements

• BS or BA in a relevant scientific discipline or above
• At least 3+ years of working experience as Clinical Research Associate/ at least 5+ year of working experience as Clinical Research Associate for senior position
• Must have 3+ years of site monitoring experience in Hong Kong/ Singapore and/or Asia countries and experience in managing Oncology studies is a definite advantage.
• Thorough knowledge of FDA/Asia Regulatory Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Prior experience in working in both pharmaceuticals and CROs is preferred
• Excellent teamwork, communication, decision-making and organizational skills are required
• Working knowledge and experience with Word, PowerPoint and Excel
• Must have excellent communication skills in English and Chinese (including Mandarin)
• International and regional travel is required (approximately 10-20%)

Gilead Core Values

• Integrity (Doing What's Right)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
• Inclusion (Encouraging Diversity)

Equal Opportunities

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. It is also Gilead's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.