メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for a clinical trial.
The ICON Pharma Solutions IDEA group manages DMC and Adjudication committees that independently review clinical trial data in an effort to reduce bias and increase validity and scientific merit of trials.
【Job Description】
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Manages project in a timely manner in adherence with ICON's SOP's, ICH, GCP and appropriate regulation and liaise with other departments as necessary.
• Delivers projects in accordance with the contract, timelines and study budget
• Identifies out of scope activities and initiates budget change orders and contract amendments
• Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings
• Facilitates the electronic endpoint adjudication system for the endpoint adjudication project
• Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching I mentoring as necessary.
• Develops and maintains all trial documentation (i.e. Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
• Performs user acceptance testing of electronic endpoint adjudication system
• Performs data reconciliation
• Serves as the primary study contact for client and internal and external study teams.
• Leads internal and external study team meetings.
• Leads internal DMC and endpoint adjudication processing team.
• Develops and monitors DMC and endpoint adjudication processing workflows to maintain efficiency
• Prepares meeting agenda and facilitates the completion and distribution of meeting minutes
• Facilitates the development of project reports. Generates and distributes project reports to the study team.
• Coordinates DMC and Endpoint Adjudication
• Committee members and data review/adjudication process
• Conducts project/system specific training to committee members
• Implements Quality Control measures for adjudication process and adjudication outcomes as necessary
• Performs project finance reporting activities
• Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.
• Participates in bid defense and new proposal review activities as necessary
• Participates in internal, client, and regulatory audits
• Other duties as assigned

※本ポジションはグローバルのプロジェクトに従事いただくことから時差の関係で早朝や深夜にミーティングの対応が発生する可能性がございます

■休日：完全週休二日制

【職務経験等：必須要件】
・ビジネスレベルの英語力、日本語力（リスニング、スピーキング、ライティング、リーディング）
※グローバルラインに紐づくポジションとなり、会議の運営や議事録作成など含めて、海外とのやり取りが多く発生します
・医療業界のバックグラウンド
・臨床試験におけるデータベースに関する何かしらの知識、経験

■職種未経験者：可