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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Clinical Operations Leader / クリニカル・オペレーションズ・リーダー(東京・大阪・神戸)

求人ID 52495BR ロケーション 東京都, 東京都 仕事内容
クリニカル・オペレーションズ・リーダー(以下COL)は、開発部門としての成果物(タイムライン、質、生産性)を確実に提供するために、プロジェクト・リーダーやスポンサーと連携を取りながら、クリニカル・チームを取りまとめる責任を持ちます。
COLはプロジェクトにおける臨床オペレーション戦略の実施全般において説明責任を負います。
なお、プロジェクト・リーダーが任命されていないような小規模なプロジェクトにおいては、プロジェクト・リーダーとしての役割も担います。
責任者として任命された業務は、グローバル・リサーチ・オペレーションの全ての規律を含むものとします。

- 1プロジェクトのメンバー数:3名~30名
- COL一人あたりの担当プロジェクト数:1~2プロジェクト

■募集部門: 臨床開発部

The Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy on the project. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. Tasks assigned as responsibility include all aspects of the GRO discipline. Provides work direction to project team members as appropriate and works closely with all project team members.
Key Accountabilities:
• Effectively communicate with internal and external customers as well as third party vendors
• Prioritize effectively and respond to urgent requests within team or from sponsor.
• Manage study start-up activities, in small size studies
• Provide input to project tools, PL project plan, Central File Maintenance Plan
• Provide input to the format and content for sponsor reports
• Provide input to and oversight of site selection strategy plan
• Develop site selection and monitoring plans for the team
• Review and provide input into patient recruitment plan and retention plan
• Ensure all team members have access to tools and documents
• Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program
• Develop study plans, tools and forms. Project Implementation, Control & Evaluation
• Provide leadership and direction to project team members
• Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists
• Evaluate and identify resourcing needs and continuously monitor over life cycle of project
• Provide productivity targets to project team members
• Provide performance feedback on team members as appropriate
• Address identified and escalated site issues and drive to closure
• Early recognize areas of potential problems and provide input to contingency plans
• Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
• Oversee maintenance and quality check of Central Files
• Provide input to the Revenue Recognition forecast
• Identify changes in scope and liaise with Project Leader
• May be required to conduct site visits as per client or project demands
• Participate in client, investigator and team meetings
• Prepare, participate in and follow up on audits / inspections
• Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
• Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out Checklist
• Together with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract
• Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions Operational

Qualifications

■必須業務経験:
・臨床開発経験5年以上(CRA・PM・PL経験含む)
・臨床部門でのチームリーダーまたは同様の経験(臨床試験における部門間の調整業務実績などを含む)
臨床研究における実務経験。またはこれらと同様の臨床研究における経験
・Global Study、英語を業務で使った経験等があれば尚可

■求める人物像:
・論理的に考えられる方
・パレクセル独自のプロセスや業務システム等、新しい知識を吸収し学ぶ姿勢がある方
・Globalチームや日本の各部門間との調整業務に苦手意識が無い方

※ご応募の際には、英文CVのご提出を併せてお願いいたします。

• Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials.
• Degree in a life science, nursing qualification or relevant experience
• Competent in written and oral English
• Strong understanding of the cross functional activities
• Leadership skills
• Strong customer focus
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Effective time management in order to meet daily metrics or team objectives
• Personal skills that include: ability to take initiative and work independently, ability to successfully work in a team environment, sense of urgency in completing assigned tasks
• Excellent interpersonal, oral and written communication skills
• Excellent presentation skills
• Ability to travel as required
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