Sr Clinical Trials Manager

5 days ago

Singapore GILEAD SCIENCES SINGAPORE PTE. LTD. Full time

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%)

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