Clinical Data Specialist
Clinical Data Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
- Reporting to the Clinical Data Manager youll 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.
- Youll 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 youll 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 platform.
- Maintain audit-readiness of documentation through conformance to procedures and applicable data standards.
- Bachelors or masters degree in science or healthcare related field or equivalent practical experience.
- 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 an advanced degree in biomedical science informatics biostatistics or relevant experience.
- Aware of pharmaceutical industry health data standards such as CDISC and MedDRA.
- Passionate and collaborative problem-solver who values the opportunity to think beyond the way things are.
- Experience navigating clinical databases such as EDCs EMRs or other data management systems.
- 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.
- Strong project management organizational analytical and written and verbal communication skills.
- Self-motivator who can identify problems and propose solutions in a highly dynamic and fast-paced environment.
- Experience managing data for real-world evidence programs registries or other post-marketing studies.
Employment Type
Full Time
