Clinical Data Management Specialist
New
United StatesFull-TimeMiddle
Salary100,500 - 150,800 USD per year
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Job Details
- Experience
- Minimum of two years of Clinical Data Management or other relevant experience.
- Required Skills
- GCPMicrosoft Excel
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, or equivalent experience.
- Minimum of two years of Clinical Data Management or relevant industry experience.
- Advanced proficiency in Excel for complex data review and reconciliation.
- Experience building studies using Electronic Data Capturing (EDC) systems.
- Strong knowledge of ISO 14155, GCP, and 21 CFR Part 11 regulations.
- Ability to communicate complex requirements, strategies, and deliverables professionally.
- Experience with business process improvement tools and methodologies.
- Ability to work independently and manage obstacles within set timelines.
- Strong interpersonal and relationship-building skills for a matrix environment.
- Familiarity with CDISC or CDASH clinical data standards is preferred.
Responsibilities
- Review and contribute to the authorship of study protocols and documentation.
- Develop Electronic eCRFs, program edit/rule checks, and database specifications.
- Create UAT scripts and lead study team review processes for eCRFs and edit checks.
- Develop and maintain Data Management Plans throughout the study lifecycle.
- Manage in-stream data cleaning, validation, and database locks for in-house studies.
- Generate and distribute study metric reports on query management and site performance.
- Oversee CRO data management deliverables and external data transfer agreements.
- Conduct training on DMP and EDC systems for internal teams and study sites.
- Coordinate Trial Master File setup and archiving throughout the study lifecycle.
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