Job Description - 【Japan】JapanClinical Science Liaison Position
The CSL is responsible for all field-based support of BSC IO&E clinical trial initiatives. The CSL has an assigned territory autonomously managing, developing and growing clinical activities/initiatives achieving key clinical and medical objectives. Territory - JAPAN Identify key issues that are accelerating or inhibiting patient recruitment, quality data collection or patient retention. Recommend research sites that can perform well delivering patient enrollment and quality data. Support principal investigator and provide up to date information that may improve patient recruitment and/or data quality. Provide medical insights and updates on key findings affecting the study performance. Provides input into the development of global clinical trial strategies. Participate in IO&E franchise and study-level feasibility activities through providing key site specific knowledge including patient pathways and operational execution Interface and act as an expert on the clinical trial protocol(s) and SME providing the sites with knowledge and awareness about the current and upcoming clinical trials Contribute to the trial specific site feasibility / selection strategy and collaborate with the Clinical Trial Manager (CTM) and CRO to support the site start-up process as needed. Oversee and track patient recruitment process and pro-actively identify ways to prevent recruitment delays Proactively work to fully understand all matters that impact the successful patient recruitment and high quality conduct of the clinical trial at each site, eg the Principle Investigator (PI) and site preferences and best practices on clinical trials, standard of care treatments, competing studies etc. Ensure a supportive relationship with clinical sites and trial personnel. May participate in monitoring oversight activities such as accompanying the CRO/CRA during site visits (This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements) Optimize site engagement for a specific trial and across the IO&E franchise to ensure site engagement and quality for the site-level enrollment and execution of every trial Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the respective study CTM, CODL, Global Head of Clinical Site Communication, Recruitment and Liaisons, Head of Trial Operations and/or Senior Management, as needed Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications May be asked to provide input to the clinical development strategy/plan Participate in workstreams and provide input to procedures/SOPs/WIs and related document Through scientific exchange, discover novel investigator sponsored research (ISR) ideas. Fully appreciate novel ideas that could significantly impact patient care. Support Investigator Initiated research/study program by discovering and championing innovative ideas, facilitate study start up and provide ongoing consultation. Provide quarterly updates to senior leadership on study progress and medical/scientific insights. Build, maintain and manage effective professional peer-peer relationships with contracted External Experts (EE), or Key Opinion Leaders (KOL) engaging in bi-directional scientific/educational exchange. Investigate and gather field medical intelligence/insights that might affect therapy safety/efficacy, Clinical/R&D strategies and competitive activities. Bachelor's degree required, terminal degree in clinically related area preferred (PharmD, PhD, MD/DO) Over 5 years experience functioning in an industry medical or clinical role supporting clinical trials. Track record for creating, managing and completing medical/scientific related projects. Clinical trial acumen; preferably having clinical trial experience and knowledge of GCP Preferred experience Oncology experience or demonstrated ability to master new therapeutic areas. Industry experience in a clinical, medical or scientific liaison role Field experience Medical devices experience Outstanding interpersonal consultative skills Excellent presentation/platform skills Proficient in verbal and written English Detail oriented Self-motivated continuous scientific, technical and medical learning Ability to manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges Ability to creatively address problems in an organized systematic way Willingness and ability to work within and outside of traditional business hours Collaborative style, responsive, considerate, flexible, assertive and personable Strong knowledge of Microsoft Office Products and web based customer and clinical support tools Ability to travel extensively within Japan Some international travel may be required. Physical ability to operate interventional instrumentation
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