Location: Home-based

Job summary: Join a sponsor-dedicated CDM team to make an immediate impact on study success for a Biopharma company - working fully within the sponsor environment. The Clinical Data Manager will perform data management activities for Phase I, II and III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials are on-time and with the highest achievable quality.

Key Responsibilities:

• Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.

• Communicate key clinical data management metrics (data entry status, query resolution and aging, etc.) and determine appropriate actions along with study team members.

• Develop, review and/or write clinical trial documents and manuals such as Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.

• Participate in User Acceptance Testing (UAT), as needed.

• Work with Clinical Database Programmers to ensure the development of data flow charts, data transfer specifications and import guidelines.

• Perform data review and discrepancy resolution, as needed.

• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.

• Support GCP inspection readiness.

Qualifications:

• 5 years of clinical data management experience.

• BS/BA in a scientific discipline or certification in health profession from accredited institution.

• Experience with Electronic Data Capture (EDC) system is required.

• Experience with Oracle Inform is preferred.

• Oncology and/or Inflammatory therapeutic area experience is preferred.

• Project management experience (within CDM) is preferred.

• Work history at a Clinical Research Organization (CRO) or CRO management experience within data management is preferred.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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