Your Role:

• Accountable for day to day activities of all aspects for the management of local and/or regional company sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
• Accountable for the  oversight of ISS granted by our company,  including the support of the set-up  and  operational assessment of investigator-sponsor,  tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
• Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
• Develop and monitor study budget and timelines
• Monitor work to ensure quality
• Ensures that trial status is tracked and entered into the respective Clinical Trial Management System 
• Contribute to the planning and set-up of a study  and provide planning parameters , Support early access programs on the country level 
• Provide product expertise and/or oversight at the country level to external consultants and/or flexible staff working on company sponsored clinical studies
• Lead at the regional level early access programs in collaboration with the Product CRM Lead.
• Understanding of local / country and regional requirements for clinical trials 
• Managing and steering CROs 
• Proactive issue monitoring and management
• Manages the budget for all local clinical studies  in own country, regional study in own hub, and Global Phase IV studies as well as the IST/ISS grants
• Coordinate within own region the study management for all local and regional clinical trials across all phases and therapy areas, as well as IST/ISS and EAP activities
• Support local and regional organizations in delivering local medical strategy across the portfolio within own region
• Work with CRO/external consultantis in country / region to ensure local / regional trials are delivered within desired quality, timelines, and costs
• Act as an interface between Global Clinical Operations and local organizations (Global Operations)
   

Who You Are:

• Medical or Life Sciences degree or equivalent qualification
• At least 8 years of experience in clinical research in a CRO, pharma or biotech company 
• Good understanding of APAC regulatory and local requirements for clinical trials
• Thorough knowledge of ICH GCP 
• Demonstrated good interpersonal skills
• Demonstrated good written and verbal communication skills
• Demonstrated good presentation skills
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way 
• Analytical skills, quick perception and good judgement
• Fluency in English (oral and written) plus local language

•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다

•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)