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Sr Clinical Trials Manager
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The **NEW **position is responsible for execution of phase 1-3 clinical trials **with a strong focus in oncology **in Asia Pacific region, in partnership with global clinical operations team and other relevant functions.
**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.
Must have 3+ year regional oncology study management experience in Asia Pacific region
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
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 mínimal 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%)
