募集要項
| 業務内容 |
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 our 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 our 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.; |
|---|---|
| 雇用形態 | 正社員 |
| 応募資格 |
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 our solutions.; • Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills. • 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 skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint. • 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. • Core Competencies - Ability to demonstrate all our competencies (Client Focus, Collaboration, Communication, innovation, Ownership). |
| 英語力 | ビジネスレベル |
| 年収 | 700万 〜 1200万円 |
| 給与詳細 |
月額基本給:318,000円～454,000円 時間外・休日勤務割増賃金支給 ※経験・能力・資格等考慮し、弊社規程に則して決定します 想定年収：700万～1200万円 |
| 勤務地 | 東京都 |
| 備考 |
企業情報
匿名
関連する求人
この求人は当社のグループ企業によるものです。 当社は製薬会社から受託される治験薬臨床試験に必要な臨床検査業務を行っています。 現在の受託可能検査項目は、生化学検査・血清学検査・感染症スクリーニング・血液学検査・血液凝固学検査・尿一般検査・細胞性免疫（フローサイトメトリー）検査です。 Job Overview ・臨床検査事業における、プロジェクトコーディネート業務全般 ・プロジェクトマネージャーと協力し、治験立ち上げのサポート、進捗管理、タイムライン管理、リスクマネジメント等 ・治験依頼者や施設モニターからの問い合わせ対応 ・ラボ運営、検査実施プロセスの改善提案 ・検体の受け取り、保管、検査の進捗状況に関するモニタリング業務 ・海外チームとの連携 ・上長は同じオフィス所属の日本人マネジャーです ・他部署とのコミュニケーションは英語で行うことが多く、英語力を活かしたい方には最適です。 ・グローバル規模の治験に携わることができ、日本のみならずアジア全体のプロジェクトに関わり、活躍する機会があります。 ・業務を通して、治験のみならず、海外、主にAPACの規制など、多岐にわたり学ぶことが出来ます。 ・業界未経験の方でも、独自のトレーニングや業務を通じて治験全般について学べる機会はあるので、やる気のある方であれば将来的にはプロジェクトマネージャーとして活躍していただけます。
- 350万〜550万
- 東京都
- CRO
募集中
Line management of Clinical Research Associates (CRAs); Recruitment, initial and continued training and development of CRAs; Oversight and Management of CRAs to ensure CRAs are meeting expectations of core monitoring responsibilities; Tracking and management of CRA resourcing/allocation of assignment; and Manage turnover and retention of CRAs to meet company objectives
- 780万〜1300万
- 大阪府
- CRO
募集中
Efficiently manage and successfully execute all aspects of global project start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; Present during bid defenses, general capabilities meetings, and audits.
- 780万〜1300万
- 大阪府
- CRO
募集中
■職務概要 クリニカルトライアルエデュケーター（CTE）は、担当試験の治験実施施設の患者登録において障害にあたるものを特定・分析し、患者登録促進のための提案をします。 ■職務詳細 ・治験実施医療機関訪問（オンサイトあるいはリモート面会）、電話 ・メールによるコンタクト ・治験で使用機器を使用する方法についてトレーニングの実施（看護師に限る）・各種レポート作成、クライアント会議への出席と報告、社内会議への出席と情報共有など
- 550万〜1000万
- 大阪府,東京都,福岡県
- CRO
募集中