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      Role Summary
 A current student, working with the Data Management & Clinical Data Standards (DM & CDS) team, will help ensure the integrity, quality and readiness of clinical trial data across Phase 1 – IV studies. Requires collaboration within the department as well as other functions including Clinical Operations, Biostatistics, Statistical Programming, and Safety to support database build, data cleaning, and reporting – gaining hands-on exposure to industry tools and standards (e.g., ICH-GCP, CDISC).
 
 Responsibilities
 
  - Participating in planning, testing, and implementation of automating clinical data systems and data transfers.
 
  - Participating in the process of improvement and optimization efforts.
 
  - Assisting and learning about trend evaluation and escalations.
 
  - Working within MDR application to develop collection metadata.
 
  - Participating in central monitoring activities utilizing disparate datasets.
 
  - Processing documentation in a compliant environment.
 
 
 
 Qualifications
 
  - Enrolling in, or having completed, at least an associate’s degree from a recognized accredited educational institution.
 
  - Preferred courses of study include health sciences, biological sciences, clinical research, life sciences and public health.
 
  - Preferred experience with metadata, XML, CDISC, Clinical Data Collection, and metadata repositories.
 
  - Curious, eager, open to learning, and independent.
 
  - Highly analytical and can communicate conclusions from large and small data sets.
 
  - Research oriented mindset including critical thinking skills or desire to develop these skills.
 
  - Excellent organizational, record keeping, oral and written communication skills.
 
  - Team player, detail oriented and organized.
 
  - A desire to make an impact as part of a high-growth, transformational company.
 
  - Must have work authorization in US without the need for future sponsorship.
 
 
 
 Skills
 
  - Analytical thinking and ability to interpret data sets
 
  - Strong communication (oral and written) and collaboration
 
  - Attention to detail and documentation practices
 
  - Ability to work in a compliant regulatory environment
 
 
 
 Education
 
  - Associate’s degree or equivalent; preferred life sciences or health-related fields
 
 
 
 Additional Requirements
 
  - The co-op duration is January to July, 2026, 40 hours per week, on-site.