【アステラス製薬】Clinical Trial Lead
仕事内容
https://astellasjapan.avature.net/en_GB/careers/JobDetail/Clinical-Trial-Lead/3392
• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
• Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
• Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
• Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
• Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
• Lead feasibility assessment and selection of countries and sites for trial conduct
• Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
• Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
• Participates in inspection readiness activities including coordination of clinical study team deliverables
• Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
• Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
• Facilitate and manage regional KOL interactions, as applicable
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
• Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
• Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials
応募資格(必須経験など)
＜必須 / Must＞
• BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
• Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
• Requires proven project management skills and trial leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
• Fluent in English
• Moderate (~25%) travel required
＜歓迎 / Preferred＞
• Advanced Degree