Business Operations Manager - Study Start Up Manager

Description 【募集の背景 / Purpose & Scope】This position sits within Clinical Operations Excellence (COE) and serves as an expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. They will have a deep understanding of global site activation requirements and data flows across Astellas applications and reporting tools. The Business Operations Manager will represent Clinical Operations both early and late on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across various therapeutic areas, trial designs, and global requirements to support development of robust functional requirements for new or enhanced applications and reports. This role will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions used for clinical systems. This role will work with business process and system owners to define user roles, permissions, and training requirements. This position may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members. 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後）

• Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP / ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
• Manage and may lead functional and cross-functional internal teams
• Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems / tools
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Responsible for implementation of standards for designated functional areas.ASTELLAS POSITION DESCRIPTION For Astellas internal use only Page 2 of 3 Rev. 3 / 22 / 24
• Provide oversight and direction to team members for functional and study-related deliverables
• Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
• Responsible and may be accountable for all activities associated with Study Start Up. This may include :
• Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB / EC submissions, IMP Release and other site activation requirements
• Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period
• Building relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU
• Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
• Contributing to process and tool development to the support of the SSU team with day-to-day activities
• Leading the preparation of study level essential document templates
• Aiding in the preparation of content for Regulatory submissions
• Supporting ICF negotiations and escalation
• Review and Approval of IMP Release Packages （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 FlexibilityGuidelines. 【応募要件 / Qualifications】 ＜必須 / Required＞
• BA / BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
• Must have knowledge of clinical trial conduct, including, multi-center, global trials.
• Must have strong knowledge of ICH / GCP guidelines and regulatory requirements.
• Requires proven project management skills and leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.
• Minimal (10-15%) travel required ＜歓迎 / Preferred＞
• Experience in working cross functionally and with external providers
• Experience with development & implementation of process improvement related initiatives
• Global Experience with site activation activities including submission requirements.