Clinical Data Transformation Lead
Remote CA-Remote, United States
ICON plc
ICON is the world's leading clinical research organisation, providing outsourced clincal development and commercialisation services to the pharmaceutical, biotechnology and medical device industries.Overview
The role involves being a Clinical Data Transformation Lead in the Clinical Data Management area, focusing on enhancing data review and cleaning processes with innovative reports. It entails creating and implementing study- specific data validation procedures and reports, managing the connection to varied data sources, and ensuring efficient scheduling, monitoring, and maintenance on the Clinical Data platform. The role requires detailing key d handling requirements for scalable data management methods, and deriving study-specific monitoring and validati reports based on clinical protocols and amendments. Ultimately, this position aims to advance clinical data management and informatics by improving data integrity, efficiency, and capacity for expansion.
Responsibilities
- Engage closely with Global Development business units such as BDM, Safety, Precision Medicine, Pharmacometrics, Digital Health to deeply understand data quality, monitoring and validation needs and transform these insights into detailed business requirements for clinical data products.
- Act as the primary point of accountability, responsibility, and expertise in interpreting Clinical Data business needs, meticulously translating and documenting these into comprehensive business specifications at the segment, modality, and company-wide levels.
- Demonstrates a business understanding of study specific data to identify and assist in successful application of consistent data management processes and documentation across assigned programs, e., ensuring consistency across data quality plans.
- Thoroughly document the clinical product development process, including data sources, methodologies, algorithms, and underlying assumptions, to guarantee transparency, reproducibility, and auditability of clinical data products.
- Craft study-specific Data Quality specifications and define key Clinical data metrics to uphold the highest data quality and integrity standards across study lifecycles.
- Prepare study-level reports within the Clinical Data Platform to support stakeholder activities and ensure the effective use of clinical study data.
- Query small to large clinical data sets, manage data ingestion and delivery specifications, and data modeling requirements. analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of da
- Design clear, concise requirements for clinical reports and dashboards, establishing relevant metrics to convey data-driven insights Present findings in a compelling manner, customized for key clinical business functions such as Clinical Data Management, Pharmacometrics, Precision Medicine, etc.
- Work towards preparing Common Data Model mapping & transformations to ensure data is usable in the analytical layer/ and comply with the Governance Committee strategy.
Qualifications
- Have a bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required.
- Candidate should have substantial experience, ideally over 7 years, specifically within clinical data analysis and preferab within the BioPharma sector
- Have hands-on experience with various clinical datasets such as EDC and non-crf dat combined with strong analytical abilities capable of managing diverse, large, and complex datasets, which ranges from fundamental research collections to detailed clinical information.
- Possess a deep understanding of modern data analytic frameworks and technology, which includes expertise in Big Data structures, Lakehouse architectures, as well as contemporary techniques for data collection and amalgamation.
- Have full understanding of clinical trial
- Have a passion for championing and implementing clinical data
- Should have practical experience with ETL processes, programming languages such SQL, Python, R, and familiarity with the AWS cloud infrastructure, including S3, Da Lake, along with analytics realms
- Have strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and
- Possess Excellent communication, and project management skills.
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Architecture AWS Big Data Computer Science Data analysis Data management Data quality ETL Python R Research SQL Statistics
Perks/benefits: Competitive pay Flex hours Health care Insurance Medical leave Transparency
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