JPN_【Clinical Science】Clinical Project Manager

Clinical Project Manager　（Specialist）

＜業務概要＞

医療機器の承認取得にむけた治験の実施や臨床データ部分の承認申請の責任を持つ。
また、海外データを用いた承認申請や、市販後の使用成績調査等の実施と使用評価申請の責任を持つ

• プロジェクト（治験、使用成績調査、製造販売後臨床試験など）を計画、立案、準備、実施し、医療機器の安全性、有効性データを収集

• 収集した臨床データによる承認申請、使用成績評価申請と関連する行政対応

• プロジェクトの予算、タイムライン、マイルストーンの管理と計画通りの達成

• 治験で使用する機器の製造、輸入計画の立案、海外手配と国内機器管理プロセスの構築

• 国内外の各種ベンダーの選定、契約、管理

• プロトコル、治験機器概要書、その他治験等関連文書の作成

• 医療機関との契約、費用交渉の管理、承認

• プロジェクト会議の運営、進行及びクリニカルリサーチアソシエイト、データマネジメント、バイオスタット、セーフティー、医学専門家、フィールドクリニカルスペシャリスト、本社臨床開発チームとの協働

• 医療機関の責任医師、分担医師、コーディネータなどとの関係構築と連携

• 既存の海外データを最大限使用した承認申請

＜想定ジョブレベル＞

Specialist（マネジャー未満）

（プロジェクトを取りまとめ、治験を実施できる方である必要がありますが、将来のマネジャー候補として今後の成長が見込める方として、Specialist（もしくはP3）での入社を想定）

The Clinical Project Manager supports Clinical Project Management in the areas of product development and commercialization through the execution of Clinical Trials. He/She has knowledge of Clinical Project Processes and can execute trial related activities without guidance. He/She is familiar with internal Clinical SOPs, has knowledge of GCPs and understands the Clinical Study Protocol.

■　Key Responsibilities 

• Contributes to protocol, ICF, IB and Reg submission creation.
• Executes CDAs and supports creation of CSAs and site budgets.
• Attends Clinical Project Meetings and manages Meeting Minutes.
• Executes study payments, manages device tracking/accountability and responsible for site management activities.
• Uses internal systems to update project milestones and study timelines.
• Manages Master study file.
• Creates site Regulatory binders and other site materials.

■　Job Level

The position requires skills in organizing projects and conducting clinical trials, but we are looking for a specialist (or P3) who is below manager level and has potential for future growth.

■　Knowledge 
A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.

■　Problem Solving 
Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique, and solutions may serve as precedent for future decisions.

■　Planning and Organization 
Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.

■　Discretion/Latitude; Supervision Received; Decision Making 
Works without appreciable direction. Works independently on highly specialized projects with long range objectives.  Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.

■　Business Relationships and Project Management 
Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources.  Provides leadership to business units.

Boston Scientific