Clinical Trial Manager

Description 【募集の背景 / Purpose & Scope】

• This position is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include : pre / post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
• Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.【職務の内容 / Essential Job Responsibilities】（雇入れ直後）
• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP / ICH guidelines and other regulatory requirements.
• Leads or supports cross-functional trial teams, including vendors.
• Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders.
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
• Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
• Participate in or facilitates site engagement and communications with investigators and / or staff to support trial milestones and deliverables.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
• Provide oversight and direction to trial team members for trial deliverables.
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems.
• Ensure quality and completeness of TMF for assigned clinical trials.
• Participates in inspection readiness activities including coordination of clinical trial team deliverables.
• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.（変更の範囲） 会社内での全ての業務【就業環境に関する要件 / Specific Physical or Environmental Requirements】At Astellas we recognize the importance of work / life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.【応募要件 / Qualifications】＜必須 / Must＞
• BA / BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS / PhD / PharmD) with at least 2 years clinical trial experience.
• Must have strong knowledge of ICH / GCP guidelines and regulatory requirements.
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Requires 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