临床数据创新经理（远程，IT）
Clinical Data Innovation Manager (Remote, IT)
关于我们
Chiesi 是一家拥有 90 年经验的以研究为导向的生物制药集团，在 30 多个国家开展业务，总部位于意大利帕尔马。集团内超过 8,000 名员工有着共同的目标：为我们的人员、患者和地球创造更健康的世界。这是我们研究、开发和推广创新药物的动力，覆盖我们主要治疗领域。了解更多 here
在 Chiesi，我们着眼于未来几代人，以可持续的方式推动有目的的创新。这培养了各级的可靠性、透明度和道德行为文化。作为一家 Benefit Corporation 和认证的 B Corp，我们已将可持续性纳入公司章程，并持续衡量我们的影响。
多元化和包容性是我们核心价值的一部分。我们相信差异让我们更强大。我们是一个充满活力的生态系统，由具有奉献精神、才华横溢的个人组成，他们有着共同的价值观，每个人带来独特的视角，帮助我们不断挑战现状，以实现更好的结果。
Chiesi 全球罕见病事业部
Chiesi 全球罕见病事业部是 Chiesi 集团于 2020 年 2 月成立的一个业务部门，专注于研究、开发和推广针对罕见和超罕见疾病的治疗方案及患者支持服务，许多疾病目前缺乏或没有有效治疗手段。
该部门位于马萨诸塞州波士顿，与帕尔马总部有很强的协同效应。
罕见病部门专注于溶酶体贮积症、罕见血液病、眼科疾病和罕见免疫缺陷的治疗研究和产品开发。该部门也是全球科研、患者倡导和护理领域的领先机构的合作伙伴。了解更多 here
我们正在寻找
这是您将要做的
临床数据创新经理负责在整个全球罕见病产品组合中制定并执行临床数据创新战略。该职位推动新兴技术、人工智能、自动化、高级分析和现代数据管理方法的应用，以加速临床开发、提高数据质量、提升运营效率并增强监管准备度。
该职位在临床数据管理、统计学、统计编程、临床运营、数字/IT 和外部合作伙伴之间发挥战略桥梁作用，以现代化临床数据流程并建立面向未来的临床数据体系。
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About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
What we are looking for
This is what you will do
The Clinical Data Innovation Manager is responsible for defining and executing the clinical data innovation strategy across the Global Rare Disease portfolio. The role drives the adoption of emerging technologies, artificial intelligence, automation, advanced analytics, and modern data management methodologies to accelerate clinical development, improve data quality, increase operational efficiency, and enhance regulatory readiness.
The individual serves as a strategic bridge between Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Digital/IT, and external partners to modernize clinical data processes and establish a future-ready clinical data ecosystem.
You will be responsible for
Strategic Leadership
- Define and maintain the Clinical Data Innovation roadmap aligned with organizational objectives.
- Identify opportunities to leverage AI, machine learning, automation, and digital technologies across the clinical development lifecycle.
- Establish long-term strategies for clinical data architecture, interoperability, standardization, and data reuse.
- Serve as innovation ambassador within Clinical Development and across R&D.
AI and Automation
- Lead evaluation, implementation, and governance of AI-enabled solutions supporting: Data review & Data cleaning, Query generation, Medical coding, Risk-based quality management, Database build automation, (Automated) Metadata generation, regulatory submission preparation
- Develop frameworks and standard operating procedures for responsible and compliant AI use in accordance with company governance and regulatory expectations.
- Monitor emerging technologies and assess applicability to clinical development.
Data Management Transformation
- Drive modernization of clinical data management processes and operating models.
- Lead initiatives to improve scalability and efficiency across internal and outsourced studies.
- Optimize interactions between Data Management, Programming, Biostatistics, Medical Writing, and Clinical Operations.
Technology and Platform Leadership
- Act as business owner and subject matter expert for clinical data technologies. Collaborate with IT and Digital functions regarding EDC platforms, Data lake architectures, Analytics environments, AI platforms and Data visualization tools
- Lead vendor evaluations and technology selection processes.
- Establish KPIs demonstrating technology value and business impact.
Advanced Analytics and Insights
- Promote use of advanced analytics and visualization to improve study oversight.
- Enable near real-time monitoring of data quality, study conduct, operational performance and Risk indicators
- Partner with Biostatistics and Programming to enhance integrated data review capabilities.
Innovation Management
- Build and manage a portfolio of innovation initiatives.
- Prioritize projects according to strategic value, feasibility, risk, and return on investment.
- Establish business cases and success metrics for innovation projects.
- Present innovation strategies and outcomes to senior leadership.
Cross-Functional Collaboration
- Partner closely with stakeholders within R&D and related to R&D (i.e. Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Quality Assurance, IT)
- Build relationships with external vendors, technology providers, and industry consortia.
Team and Capability Development
- Develop organizational capabilities in AI, automation, and innovative data practices.
- Mentor teams on emerging technologies and new ways of working.
- Foster a culture of experimentation, continuous improvement, and innovation.
- Contribute to workforce planning and future capability models.
You will need to have
- Master’s degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Computer Science or related field.
- 10+ years of experience in the pharmaceutical, biotech or CRO industry, with strong exposure to clinical development.
- Solid experience in Clinical Data Management and the clinical trial data lifecycle.
- Proven experience in AI, automation, advanced analytics and/or digital innovation applied to clinical development.
- Experience with clinical data technologies, data architecture, interoperability and data standards.
- Strong cross-functional leadership experience across Clinical Development, Data Management, Biostatistics, Clinical Operations and IT/Digital.
- Proven track record of leading clinical data innovation and transformation initiatives, including vendor and technology management.
Location
Europe with hybrid or remote options.
Compensation range
The budgeted salary range approved for this role is between €59.000 and €74.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.
Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.
This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.
The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
Originally posted on Himalayas