Clinical Data Specialist

Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Clinical Data Specialist to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?
What You'll Do
In this role, you'll work with the Clinical Data team to interpret and organize clinical oncology data. Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process. You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality. In addition, you'll work alongside other team members on ways to improve data models:

• Manage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverables
• Plan and execute real-world data management activities through the lifecycle of a product, including data model development, data processing methods (e.g., abstraction, structured, machine learning, etc.), design of data capture forms and associated instructions, creation of quality check logic, analysis of controls for efficiency and effectiveness, and development of quality check resolution guidance
• Surface opportunities for product enhancements by leveraging feedback channels, including but not limited to client requests, clinical landscape developments, industry trends, regulations, and/or data processing challenges
• Plan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production cost
• Contribute to the development and maintenance of internal and external real-world data variable user guidance
• Identify opportunities for improvement in processes/workflows, contribute to problem-solving discussions with stakeholders, and support the design and implementation of solutions, including but not limited to tooling, templates, or modifications to software platforms
• Maintain audit-readiness of documentation through conformance to procedures and applicable data standards

Who You Are
You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you have 2+ years of experience working in clinical data management, clinical or lab research, and/or related work experience in a medical device or pharmaceutical industry/company.

• You have experience navigating clinical databases such as EDCs, EMRs, or other data management systems
• You are familiar with clinical research and medical product development, clinical trial processes and related regulatory requirements or information governance frameworks (e.g. ICH GCP, Good Clinical Data Management Practices, 21CFR11, HIPAA)
• You are aware of pharmaceutical industry health data standards such as CDISC and MedDRA
• You have strong project management, organizational, analytical, and written and verbal communication skills
• You are a self-motivator who is able to identify problems and propose solutions in a highly dynamic and fast-paced environment.
• You have a Bachelor's or Master's degree in science or healthcare related field, or equivalent practical experience
• You have experience with data extraction language (e.g., SQL, SAS, R, Python, etc.) and/or data analysis platforms (e.g., PowerBI, SPSS, Tableau).
• You have a foundational knowledge of statistics and experimental design

Extra Credit

• You are familiar with all aspects of how cancer is treated, from diagnosis to recovery, and are fluent in cancer terminology
• You have experience managing data for real-world evidence programs, registries, or other post-marketing studies
• You are familiar with machine learning model development
• You have an advanced degree in biomedical science, informatics, biostatistics, or relevant experience

Where you'll work
In this hybrid role, you'll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website.
Preferred Primary Location: Durham office
The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.