外資系メディカルソリューション企業でのFSP Clinical Leadの求人

【主な業務内容】
・臨床試験の品質、タイムラインの管理
・リスクマネジメントプランのレビュー、実施
・プロジェクトメンバーとなるCRAやCRA LMなどとの社内の調整・進捗管理
・スポンサー企業側や他部門との調整、進捗管理（日本、及びグローバルで対応）
・他国クリニカルリード等との協業

●Essential Functions
Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
May be responsible for delivery and management of smaller, less complex, regional studies.
Develop integrated study management plans with the core project team.
Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with our business development representatives, as necessary.;
Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
Ensure the financial success of the project.
Forecast and identify opportunities to accelerate activities to bring revenue forward.
Identify changes in scope and manage change control process as necessary.
Identify lessons learned and implement best practices.
May be assigned as the primary contact for vendors leading project ve

【必須要件】
・ Life sciences 関連の学士号
・CRO・製薬メーカー・医療機器メーカー・バイオベンチャーで、以下ご経験をお持ちの方
・臨床開発の実務経験　4年以上　（CRA経験含む）
・グローバルスタディの実務経験
・臨床部門でのチームリーダー/スタディーマネージャーまたは同様のご経験

【付帯要件】
・英語力：Reading、Writing、Speaking、Listening　いずれもビジネスレベル以上
＊TOEIC650点以上を目安としていますがこれから勉強する意欲が高い方も歓迎
※Non-Onco phase1試験のご経験をお持ちの方（CRA経験を含む）も歓迎しております（1年以上のCRAリーダーなどのリード経験でも可）