Data Management Specialist
3 hours ago
System One Holdings, LLC
About the JobWe 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 SummaryThe 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.
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.
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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