アステラス製薬：Clinical Site Manager II（臨床開発モニター/ Site Monitor/ CRA）
仕事内容
【About Astellas】
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. （HP：Learn more about Astellas）
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
【募集の背景 / Purpose & Scope】
A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
• Site Selection
• Pre-trial assessment
• Site level Study Participant recruitment/retention plans
• Site Activation/Initiation
• On-site and remote monitoring
• Overall site relationship management in collaboration with other sponsor roles that interact with the site
• Close-out activities
Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
応募資格(必須経験など)
【応募要件 / Qualifications】
＜必須 / Required＞
• BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience.
• Five years site monitoring and/or site management experience.
• A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong critical thinking and problem solving skills.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel up to 40% with overnight stay away from home.
• Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
• Good written and oral communication.
＜歓迎 / Preferred＞
• Experience working cross-functionally and in matrix teams
• Experience in executing Lead CSM role
• Experience mentoring more junior site monitors or site managers
• Experience working in early development studies