Clinical Data Manager

2 days ago


South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time
Job Title: Clinical Data Manager

At Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for providing leadership and strategic planning for clinical systems, including vendor selection, budgeting, and resource planning.

Key Responsibilities:
  • Design and implement clinical study databases, including CRF design, database development, and testing.
  • Develop and manage standard operating procedures (SOPs) for clinical investigation data management.
  • Provide study-level metrics and reports, including data entry, monitoring status, and query status.
  • Collaborate with cross-functional teams to implement and govern CDM processes and standards.
  • Review clinical data to ensure consistency, integrity, and accuracy.
Requirements:
  • Bachelor's Degree in a scientific discipline (RN or advanced degree preferred).
  • Years of industry experience in CDM, with at least years in a lead role for clinical development programs.
  • Thorough knowledge of CDM standards for medical devices.
  • Expertise in development, validation, and management of clinical study databases.
  • Working knowledge of GCP, ICH, and FDA guidance and regulations.

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Clinical Data Manager, we encourage you to apply for this exciting opportunity.


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