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Study Data Coordinator

2 months ago

South San Francisco, California, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking a highly skilled Clinical Data Manager to oversee data management activities for multiple clinical studies. The ideal candidate will have a strong background in data management processes, systems, and industry standards.

Key Responsibilities
  • Develop and implement data management plans, including data validation and quality control procedures.
  • Design and review case report forms (CRFs) and electronic CRFs (eCRFs) for data collection.
  • Collaborate with clinical study teams to develop and review study protocols.
  • Define data collection requirements and ensure alignment with study objectives and regulatory requirements.
  • Coordinate with external vendors, such as central laboratories and EDC providers, to ensure timely and accurate data delivery.
  • Monitor vendor performance and compliance with data management standards.
  • Conduct data reviews and manage data queries to ensure data completeness, accuracy, and consistency.
  • Implement and oversee data cleaning activities as specified in data management plans.
  • Train internal and external staff on data management procedures, EDC systems, and study-specific requirements.
  • Develop and maintain comprehensive data management documentation, including data management plans, data transfer agreements, and data review plans.
  • Ensure compliance with industry standards (e.g., ICH-GCP, CDASH/CDISC) and regulatory requirements.
  • Participate in regulatory submissions and inspections as needed.
  • Serve as a key member of clinical study teams, providing data management expertise and support.
  • Collaborate with cross-functional teams, including Biostatistics, Clinical Operations, and Medical Affairs, to ensure alignment and achieve study goals.
  • Report data management metrics and study progress to stakeholders.
Requirements
  • Bachelor's degree in a scientific or related field (master's degree preferred).
  • Minimum of years of clinical data management experience in the biotechnology or pharmaceutical industry.
  • Extensive experience with Electronic Data Capture (EDC) systems; experience with Medidata Rave preferred.
  • Strong knowledge of data management processes, systems, and industry standards (e.g., ICH-GCP, CDASH/CDISC).
  • Proficiency in Microsoft Office and data management software.
  • Excellent organizational skills and attention to detail.
  • Strong problem-solving abilities and the ability to work effectively in a team environment.
  • Excellent written and verbal communication skills.
  • Experience with regulatory submissions and inspections is a plus.
  • Ability to travel occasionally as needed.