Data Management Specialist

3 hours ago


King of Prussia, Pennsylvania, United States System One Holdings, LLC Full time

System One Holdings, LLC

About the Job

We are seeking a highly skilled Data Management Specialist to join our team in King of Prussia, PA. As a key member of our clinical data management team, you will be responsible for overseeing the execution of data management activities at the program level.

Job Summary

The successful candidate will have a strong background in clinical data management, with a minimum of 9 years of experience in the pharmaceutical industry or clinical trials. A bachelor's degree in a related discipline is required, and a master's or doctoral degree is preferred.

Key Responsibilities
  • Collaborate with cross-functional teams to meet project deliverables with quality and on-time delivery.
  • Lead the planning and execution of data management activities on assigned studies.
  • Ensure all Data Management study documents are developed and archived.
  • Develop and maintain Data Management timelines.
  • Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting.
  • Identify and mitigate risks to Data Management deliverables.
  • Provide expertise in data management to support clinical studies.
  • Prepare recommendations for new or improved processes for data management and data flow.
  • Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
  • Direct and oversee activities of Data Management staff assigned to studies and tasks within projects.
Requirements

To be successful in this role, you will need:

  • A strong understanding of GCP and FDA regulations that govern the execution of clinical trials.
  • Experience with Electronic Data Capture (EDC) systems and Interactive Voice or Web Response Systems (IVRS/IWRS).
  • Expertise in CDASH/CDISC standards is preferred.
  • Strong problem-solving skills and people/project leadership abilities.
  • Excellent verbal and written communication skills.
About System One Holdings, LLC

System One Holdings, LLC is a leading provider of professional services to the life sciences and technology industries. We offer a competitive salary and benefits package, including medical, dental, and vision insurance, as well as 401(k) matching and paid time off.



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