Katalyst HealthCares & Life Sciences • Boulder, CO
[job_card.30_days_ago]
[job_preview.job_type]
[job_card.temporary]
[job_card.job_description]
Responsibilities:
Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems.
Perform data validation and query management to ensure data quality and compliance with study protocols.
Assist in the development of case report forms (CRFs) and data management plans (DMPs).
Conduct ongoing data review and discrepancy resolution in collaboration with clinical staff.
Generate data listings and summaries for interim and final study reports.
Ensure data handling is in compliance with GCP, ICH guidelines, and applicable regulatory requirements.
Maintain study documentation, audit trails, and data queries logs.
Participate in cross-functional study team meetings and contribute to project timelines.
Requirements:
Bachelor's degree in life sciences, healthcare, information technology, or related field.
– years of experience in clinical data management or a related clinical research role.
Familiarity with EDC systems (, Medidata Rave, Oracle Clinical, redcap).
Knowledge of GCP, ICH, and regulatory guidelines.
Excellent attention to detail, organizational, and communication skills.
Proficiency in Microsoft Excel and other data management tools.
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