Clinical Data Manager

4 days ago


San Diego, California, United States Katalyst Healthcares and Life Sciences Full time
Clinical Data Manager

Job Summary:

We are seeking a highly skilled Clinical Data Manager to join our team at Katalyst Healthcares and Life Sciences. As a Clinical Data Manager, you will play a critical role in ensuring the accuracy and quality of clinical trial data.

Key Responsibilities:

  • Provide oversight and guidance on data collection and management for outsourced and in-house trials.
  • Establish and maintain strong relationships with internal teams, vendors, and clinical research site personnel.
  • Lead the development of Electronic Data Capture (EDC) systems, including user acceptance testing plans and test scripts.
  • Oversee the set-up of clinical management systems and data transfer agreements with external vendors.
  • Write and contribute to the preparation of Clinical Data Management documents.
  • Develop EDC custom and Business Objective reports, SAS clinical programming report specifications, and data visualization output.
  • Collaborate with the Study Execution Team to review clinical documents, including protocols, statistical analysis plans, and protocol deviation plans.
  • Report Data Management metrics and trends, identifying barriers to timely and successful trial execution and proposing solutions.

Requirements:

  • Bachelor's Degree in life sciences or a related discipline.
  • 6+ years of experience in clinical data management or relevant work experience.
  • CRO or CDM vendor management experience in oncology.
  • Early phase adaptive trial management experience preferred.
  • Experience with CDASH terminology and/or MedDRA and Who Drug medical coding.
  • Experience with SAS programming techniques is a plus.
  • Experience with RaveX and/or Veeva EDC is a plus.
  • Experience with Spotfire is a plus.
  • Strong working knowledge of CDISC standards, FDA, and ICH/GCP regulations and guidelines.
  • Proficient in EDC configuration and design, testing and validation, data collection and data review process, and data standardization.

What We Offer:

We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.



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