Clinical Trial Manager/ Sr Clinical Trial Manager, Hong Kong

Clinical Trial Manager/ Sr Clinical Trial Manager, Hong Kong
China - Hong Kong

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Specific Responsibilities and skills for Position

The NEW position is responsible for execution of phase 1-3 clinical trials with a strong focus in oncology in Asia Pacific region including Australia, in partnership with global clinical operations team and other relevant functions,

reporting to Director, Clinical Operations.

Essential Duties and Job Functions

Manages geographical region(s) of a large complex clinical trial and independently manages all components of a small less complex study

Manages vendors and maintains cross functional study timelines in partnership with global study team

Partners with global study team and CRO to troubleshoot country/site specific operational issues

Establishes good relationship with key institutions and key opinion leaders (KOLs) in Asia Pacific region including Australia.

Conducts co-monitoring/oversight and relationship building visits in the region as required

Provides inputs to the review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports

Contributes to development of RFPs and participates in selection of CROs/vendors

May be asked to train CROs, vendors, investigators and study coordinators on study requirements

Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies

May serve as a resource for others within the company for clinical trials management expertise

Contributes to development of study budget and ensures effectiveness of site budget/contract process in the region

Mentors junior team members and may contribute to employee performance management

Knowledge, Experience and Skills

Must have 8+ years of experience and a BS or BA in a relevant scientific discipline. If the candidate has more experience, Senior Clinical Trials Manager may be offered.

Must have 3+ year regional oncology study management experience in Asia Pacific region, including Australia.

Must have 5+ years site monitoring experience in Hong Kong and/or Asia Pacific region.

Well versed in clinical trial processes and requirements in Asia Pacific region, including Australia.

Thorough knowledge of Regulatory Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies

Prior experience in working in both pharmaceuticals and CROs is preferred

Advanced project management skills adequate to manage the entire process of a clinical trial

Ability to identify issues and adapt to changes

Ability to work independently with minimal oversight

Ability to lead cross-functional teams internally and externally and mentors team members

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 20%)

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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