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| 部署・役職名 | FSP Clinical Lead |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【主な業務内容】 ・臨床試験の品質、タイムラインの管理 ・リスクマネジメントプランのレビュー、実施 ・プロジェクトメンバーとなるCRAやCRA LMなどとの社内の調整・進捗管理 ・スポンサー企業側や他部門との調整、進捗管理（日本、及びグローバルで対応） ・他国クリニカルリード等との協業 ＜Job Overview＞ Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and X’s suite of solutions to drive operational excellence and strategic leadership with our customers ＜Essential Functions＞ ・Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies. ・May be responsible for delivery and management of smaller, less complex, regional studies. ・Develop integrated study management plans with the core project team. ・Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. ・Set objectives of the core project team and/or sub－team（s） according to agreed upon contract, strategy and approach, effectively communicate and assess performance. ・Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. ・Monitor progress against contract and prepare/present project and/or sub－team information proactively to stakeholders internally and externally. ・Manage risk （positive and negative） and contingencies proactively and lead problem solving and resolution efforts. ・Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub－team members and planning/implementing appropriate corrective and preventative action plans. ・May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with X's business development representatives, as necessary.; ・Build the cross－functional project team and lead their efforts; responsible for managing cross－collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.; ・Ensure the financial success of the project. ・Forecast and identify opportunities to accelerate activities to bring revenue forward. ・Identify changes in scope and manage change control process as necessary. ・Identify lessons learned and implement best practices. ・May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.; ・Adopt corporate initiatives and changes and serve as a change advocate when necessary. ・Provide input to line managers of their project team members’ performance relative to project tasks. ・Support staff development and mentor less experienced project team members on assigned projects to support their professional development.; |
| 労働条件 |
【雇用形態】正社員（試用期間6ヶ月） 【給与】経験・能力・資格等考慮し、弊社規程に則して決定します。 ※年俸制。賞与分も月額基本給に加算された上で毎月12分の1相当額が支給されることになる。 賞与：なし 基本給の見直し：原則年1回（4月） 【勤務形態】 標準勤務時間：9:00 – 17:30 休憩 11:30 – 13:30 までの間の60 分 フレキシブルスタイルワーク（FSW）＊ ＊FSW は、自宅やオフィス等働く場所に捉われず効率的で生産性の高い業務を行う勤務形態。標準勤務時間を基本としつつ、深夜時間帯（午後10 時～午前5 時）を除いてフレックスタイム制が適用される。尚、クライアントプロジェクトに従事する社員等、FSW が適用されない場合もある。 【休日】 毎週土曜日·日曜日、国民の祝日、年末年始（12 月29 日～31 日、1 月2 日～4 日）、その他会社が休日と定めた日 【休暇】 年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇 ※補足 休業・休暇（無給） 産前産後休業：産前6 週間、産後8 週間（ただし多胎妊娠の場合は産前14 週間、産後8 週間） 育児休業：最長で養育する子が3 歳に達するまで 生理休暇：必要日数 介護休業：要介護状態にある家族1 人につき93 日まで 看護休暇：小学校就学前の子を看護する場合、年間12 日まで 【福利厚生】 ・社会保険：労災保険、雇用保険、健康保険、厚生年金保険 ・退職金制度：あり ・定年：満60 歳（60歳に達したとき） |
| 応募資格 |
【必須（MUST）】 ＜Qualifications＞・Bachelor's Degree Life sciences or related field Req ・Requires greater than 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. ・Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.; ・Knowledge of clinical trials － Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through X's solutions.; ・Communication － Strong written and verbal communication skills including good command of English language. Strong presentation skills. ・英語力：ビジネスレベル（読み書き会話） ・Problem solving － Strong problem solving skills. ・Leadership － Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. ・Leadership － Ability to make decisions, bringing clarity to disparate information to inform actions and drive results. ・Organisation － Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances. ・Prioritisation － Ability to handle conflicting priorities. ・Quality － Attention to detail and accuracy in work. Results－oriented approach to work towards delivery and output. ・Quality － Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. ・ITスキル：優れたPCスキル（Microsoft Word、Excel、PowerPoint などの MS Office アプリケーションを含む） ・Collaboration － Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills. ・Cross－collaboration － Ability to work across geographies displaying high awareness and understanding of cultural differences. ・Finances － Good understanding of project financials including experience managing, contractual obligations and implications. ・X's Core Competencies － Ability to demonstrate all X's competencies （Client Focus, Collaboration, Communication, innovation, Ownership）. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/10/03 |
| 求人番号 | 3690983 |
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