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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

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