高级临床数据工程师
Senior Clinical Data Engineer
当我们的价值观一致时，我们能够实现无限可能。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都基于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，都在为最终能惠及患者的疗法的发展做出贡献。我们把工作当作自己的事，带着同理心去做，并致力于带来改变。
关于Parexel
Parexel是全球领先的临床开发合作伙伴，为生命科学行业提供以洞察力驱动的临床和咨询服务。全球拥有22,000多名员工，我们与生物制药公司和研究机构合作，设计并开展以患者为中心的临床试验，扩大可及性，使研究成为任何地方任何人的治疗选择。
我们专注、敏捷且有共同目标地工作——迅速应对患者需求，加速新疗法的交付。我们鼓励大胆思考，快速适应变化，并不断推动临床研究的速度和质量的提升。我们正在扩大团队，寻找有才华的人才来推动行业领先创新，用心（With Heart®）。
关于该职位
我们正在寻找一名高级临床数据工程师加入我们的团队。作为高级临床数据工程师，您将推动数据管理解决方案的战略设计和实施，以实现高效的临床试验运营和监管合规。该职位在管理数据摄入、质量保证和报告基础设施方面起着关键作用，这些基础设施支持研究执行和患者安全。您将与包括项目经理、生物统计学家和监管专家在内的跨职能团队合作，交付首次即正确的数据解决方案。
您将加入一个快节奏、注重成长的环境，通过领先的科技创新、指导新兴人才以及建立临床数据管理的最佳实践，来产生有意义的影响。在多元化的团队和持续的学习机会中，高级临床数据工程师可以探索职业路径，扩展在临床研究、数据工程和监管科学方面的技能。
主要职责
- 领导与供应商的数据接收协议的设计、实施和管理，并与跨职能团队协调
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).
About the Role
We are seeking a Senior Clinical Data Engineer to join our team. As a Senior Clinical Data Engineer, you will drive the strategic design and implementation of data management solutions that enable efficient clinical trial operations and regulatory compliance. This position plays a critical role in managing data ingestion, quality assurance, and reporting infrastructure that supports study execution and patient safety. You'll collaborate with cross-functional teams including project managers, biostatisticians, and regulatory specialists to deliver first-time-quality data solutions.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through leading technical innovation, mentoring emerging talent, and establishing best practices in clinical data management. With diverse teams and continuous learning opportunities, the Senior Clinical Data Engineer can explore career paths and expand skills across clinical research, data engineering, and regulatory science.
Key Responsibilities
- Lead the design, implementation, and management of Data Receipt Agreements with vendors and coordinate with cross-functional teams to establish efficient data transfer protocols
- Program and establish import procedures for data ingestion using SAS, SQL, R, or alternative technologies such as Workbench, ensuring seamless integration of external data sources
- Develop and execute comprehensive reconciliation checks and validation protocols to ensure accurate and complete data transfer across all systems
- Design and program offline listings and custom reports that provide actionable insights to study teams and clients, enabling data-driven decision making
- Aggregate and manage data across multiple sources, handling missing values, raw data files, data structures, and complex programming challenges with precision and accountability
- Review and analyze data outputs to identify patterns, anomalies, and opportunities for improvement, providing strategic insights to enhance study quality and efficiency
- Maintain accountability for first-time quality on all deliverables, ensuring compliance with SOPs, regulatory guidelines, and industry standards including ICH-GCP and 21 CFR Part 11
- Lead and coordinate programming teams to successful project completion within established timelines and budgets, while monitoring resourcing and managing scope changes
- Manage the deployment and optimization of data management technologies including SAS, Workbench, R, and other systems used for creating offline listings and data solutions
- Develop, implement, and maintain technical documentation, data standards, and quality processes that ensure traceability, regulatory compliance, and operational efficiency
- Mentor and provide technical guidance to team members and project teams, fostering a culture of continuous improvement and technical excellence
- Participate in business development activities including bid defense meetings, contributing technical expertise to support new business opportunities
You'll thrive in this role if you bring:
- Advanced technical proficiency in at least one programming language (SAS, SQL, or R) with demonstrated ability to design and implement complex data solutions
- Strong leadership and mentoring capabilities with the ability to motivate and guide virtual teams across multiple time zones and cultures
- Extensive experience working in clinical research or regulated environments with deep knowledge of clinical trial processes and data management best practices
- Excellent communication and interpersonal skills with the ability to translate technical concepts for diverse stakeholders and build strong working relationships
- Demonstrated commitment to first-time quality, methodical problem-solving, and continuous process improvement in complex technical environments
- Comfort working with multiple data management systems and technologies, with the ability to quickly master new tools and adapt to evolving technical landscapes
- Strong analytical and strategic thinking skills with the ability to identify opportunities for efficiency improvements and innovation in clinical trial operations
Required Qualifications:
- Bachelor's degree in a relevant science discipline or equivalent work experience
- Minimum 5+ years of experience in clinical research, data management, or a related field
- Proficiency in at least one programming language (SAS, SQL, or R) with demonstrated expertise in data manipulation and analysis
- Hands-on experience working with at least two clinical data management systems (such as SAS, Workbench, or Elluminate)
- Strong knowledge of ICH-GCP, regulatory requirements, SOPs, system life cycle methodologies, and applicable regulations including 21 CFR Part 11
- Demonstrated leadership experience mentoring team members and managing technical projects
- Excellent written and oral communication skills in English with the ability to present complex technical information clearly to diverse audiences
Originally posted on Himalayas