Description
Make your mark for patients 患者さんのためにあなたの力を発揮してください ※フルリモート不可/Hybrid work model ※Please check if the candidate has applied for a job at UCB in the past year. 一年以内のご応募歴を必ずご確認ください。 ※Please make English and Japanese resume combined in one document to submit 英語と日本語の書類を一つに纏めてご提出ください。 ※If you have any questions, please contact recruiting team 質問がございましたら採用チームまでお問い合わせください JOB SUMMARY Primary Purpose / Regulatory Responsibilities:
• Accountable for the delivery of patient-centric studies from protocol design through to study report and archiving. These can be all types of study from First in Human to Phase 4, across all geographies and in all UCB theraputic areas including Gene Therapy.
• Accountable for the effective interface and influential stakeholder management between UCB, Phase 1 Units, Clinical Research Organizations (CROs) and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, meeting all major milestones and to budget.
• Lead study specific decision making and develop strategies for increasing study efficiencies.
MAJOR RESPONSIBILITIES • Accountable for the leadership and delivery of all assigned UCB sponsored clinical trials through effective internal and external team stakeholder management in a matrix organisation.
• Responsible for operational updates, issue/mitgations, ensuring open, transparent communication with team members, line management and Clinical Strategic Partnering, escalating within and outside the team as needed.
• Demonstrate robust oversight of sponsor-delegated activities by regularly reviewing CRO/Phase 1 Unit performance, including TMF status, through use of KPIs, metrics and deliverables (such as SQV, Impact), with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
• Responsible for Site Engagement strategies to support study recruitment at sites. Become familiar with the competitive landscapes; engage with Key Opinion Leaders (KOLs), investigational sites, patient advocacy groups and other relevant organizations.
• For assigned studies, be the key internal clinical operations contact, working closely with the respective PDL and other team members.
• During start-up, articulate study scope, goals, and expectations of UCB to the CRO/Phase 1 Unit and ensure all relevant information that may impact the set-up of the trial is highlighted and accounted for in the study planning.
• Responsible for detailed planning of study timelines to enable timely access and prompt decision making for all data for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, final data reporting for Results Interpretation Meetings and final Clinical Study Report (CSR).
• Responsible to manage, track and ensure accuracy of study budgets in UCB systems, including the forecast and accrual information.
• Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate).
• Support any audit/inspection activities, including audit/inspection readiness, ensuring findings are appropriately addressed in a timely manner and overall compliance with regulations (eg, ICH GCP) and applicable quality standards at all times.
• Identify issues/gaps in processes and interfaces with other groups and departments and develop recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.
EDUCATION & QUALIFICATION Education necessary for this role (not the education of the person)
Education Level : Bachelor's Degree
COMPETENCIES Include specific skills, behaviors, and knowledge necessary to meet the objectives of the role
Technical:
- Operational clinical project management experience (P1-4), including an understanding of the complexities of Global Clinical Development and Operations.
- Ability and experience to manage study feasibility assessments, vendor management, study start-up process, different modalities of outsourcing, data management, risk-based quality management.
- Solid understanding of budgeting process, budget follow-up and forecasting.
- Proficiency in the Microsoft office suite.
Leadership:
- Ability to lead and maintain high performing multi-disciplinary teams in a matrix environment.
- A flexible, proactive and adaptive management style.
- Excellent time management and organizational skills.
- Results and problem solving oriented. Presents "can do" attitude.
- Effectively manage and influence all stakeholder relationships.
- Excellent communication skills demonstrating clear and articulate verbal, written and presentation skills with excellent command of the English language.
- Ability to manage conflict and achieve consensus in a team.
患者さんのために価値を創造し、ご自身の力を発揮する準備ができているとお感じでしたら、ぜひ私たちにご連絡ください。
会社概要 UCBは、神経および免疫領域に注力するグローバルなバイオ医薬品企業です。世界中で約8,500人の社員が、患者さんからインスピレーションを受け、科学の力で前進しています。
UCBで働く魅力 UCBでは、単に業務をこなすのではなく、価値を創造することを大切にしています。私たちは挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。
誰もが尊重され、受け入れられ、最善を尽くせる平等な機会がある、思いやりと支援に満ちた文化が根付いています。
私たちは常に「その先」を目指し、患者さん、社員、そして地球に対して人間らしさを大切にした価値を提供しています。
UCBで働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限に引き出すことができます。
UCBでは機会均等を重視しています。すべての採用決定は、法律で保護されているいかなる属性にも関係なく行われます。
選考プロセスにおいて、ご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は、以下のメールアドレスまでご連絡ください:
EMEA-Reasonable_Accommodation@ucb.com
※なお、この問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんので、ご注意ください。
