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- Project Manager / 治験画像のプロジェクトマネジャー
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Project Manager / 治験画像のプロジェクトマネジャー
Parexel International Corporation
Tokyo, Tokyo, Japa
職務内容:
プロジェクト マネージャーは、治験画像プロジェクトのタイムライン、マイルストーンを計画し、クライアント(製薬会社の新薬開発担当)と調整をはかりながら、 品質、スケジュール、コストおよび顧客満足度を含めてプロジェクトを管理する。
メインとなる業務は以下となります。
・クライアント(製薬会社の新薬開発担当者)とのメイン窓口としてクライアントとのリレーションシップをマネジする。
・コスト、リソース、スケジュールなどのプロジェクト全体のマネジメント・仕様書・ユーザー用マニュアルなどクライアント/ユーザー向けの書類のレビュー
・営業社員と同行し、ビジネス開拓のサポート(コンペに参加など)
・翻訳会社からの翻訳(英語→日本語)のレビュー
・インド、ベルリンのカウンターパートナーとの電話会議参加
• Responsible for the delivery of Calyx products and services to sponsors within expected timelines and budget• Lead, manage and motivate the multidisciplinary team
• Resource planning and management
• Utilize project management tools to plan, track, prioritize and communicate timelines and deliverables to the project team and sponsor
• Assess project quality and risk
• Proactively investigate and resolve issues
• Manage the study to contract, including proactive management of budget, pass-through costs and contract amendments where necessary
• Actively manage the timelines considering impact on resources and revenue forecasting
• Prepares project timeline associated with the validation process
• Facilitates validation of applications
• Prepares requirements specifications documentation on project specific database application
• Conducts study start up meetings (internal and external)
• Conducts ongoing study team meetings
• Performs scheduling of activities and deliverables in conjunction with client and internal customers
• Conducts ongoing teleconferences with the client, managing the agenda and meeting minutes
• Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables
• Conducts regular communication with team members, formal and informal, regarding study status or any other changes
• Utilizes delegation skills to obtain maximum productivity and team involvement
• Performs/ facilitates project specific team training
• Receives all necessary client signatures on the critical path
• Facilitates preparation of study analysis plan/ Charter
• Manages Independent Review process
• Facilitates preparation of all study specific manuals
• Maintains necessary 21 CFR Part 11 guidance documentation
• Able to address 21 CFR Part 11 guidance with respect to project
• Maintains signed copies of all financial and study specific documentation per the SOP
• Able to identify work done as it relates to study exhibit/contract (within or out of scope)
• May assist with therapeutic departmental strategies and goals
• Use initiative and innovation to remedy problems without supervision
• Use autonomy and interpersonal skills to ensure that deliverables are met
• Ensure compliance with SOPs and other relevant FDA regulations.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Work collaboratively with eClinical program managers and Integration Managers to ensure delivery of the complete and seamless service to sponsors
• In projects with PAREXEL-CRS, proactively support the creation of a multi service and single company perception for our SponsorsQualifications■ 必要業務経験:
・IT業界でのプロジェクトマネジメント業務の経験(最低1~4年)
・コミュニケーションスキル(対人スキル、折衝、プレゼンテーションなど)
・英語力(TOEIC800点以上)
下記の経験があれば、尚可。 ・臨床試験の一般的な知識、経験
・ メディカルイメージングの知識、経験
Skills
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork.
Education
• B.A. or B.S. in scientific field (or equivalent) and/or relevant experience required
• Fluent in English
Minimum Work Experience
• Minimum 1-4 years relevant work experience. Experience in an imaging, clinical, or technical operations environment required. Knowledge of project management concepts and approaches preferred
• Proficient in Microsoft Office products including, Word, Excel, PowerPoint, Project
• Licenses, if any: (i.e. Board Certification, Medical License, imaging certificates, etc.)
• Ability to do some travel
Job posted: 2021-08-24