Clinical Trials Manager
Clinical Trials Manager
South Korea - Seoul
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. Gileads 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 companys five core values. Thats 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
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
- Must be able to understand, interpret and explain protocol requirements to others
- Provides guidance and daily oversight for the successful management of all aspects of Phase I to III and Late Phase Trials within designated program budgets and timelines
- Coordinates review of data listings and preparation of interim/final clinical study reports
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
- Contributes to development of Request For Proposals and participates in selection and management of CROs/vendors
- Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements
- Contributes to development of study budget
- Able to examine functional issues from an organizational perspective
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Excellent interpersonal skills and demonstrated ability to lead is required
- Thorough knowledge of ICH Guidelines, Korea regulations and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel
- Domestic and/or International travel is required
- To serve as the local Clinical Operations representative and point of contact for key stakeholders of the responsible project
- To partner with US study team and CRO to maintain cross functional study timelines and troubleshoot country/site specific operations issues
- To leverage local knowledge and relationships and to work collaboratively with Gilead affiliate personnel (Medical Affairs, Regulatory, Drug Safety and Public Health) to ensure optimal support for Gilead's clinical development programs and to ensure relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary
- To manage Post Marketing Surveillance successfully with a collaboration with CRO and other functional teams like Data Management, Epidemiology, Drug Safety and Public Health
- To provide operational support to Medical Affairs in the oversight of local/regional Investigator Sponsored Trials (ISTs)
At least 6+ years of experience and a BS/ BA/ RN in a relevant scientific discipline
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/South-Korea---Seoul/Clinical-Trials-Manager_R0022266-1
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