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Job Overview

The Clinical Data Manager (CDM) is responsible for managing data activities for Phase I-III clinical trials, ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines. The CDM ensures trials are completed on time, within budget, and with the highest quality.

Key Responsibilities:

• Serve as the primary data management representative on multidisciplinary project teams.

• Communicate key clinical data management metrics (e.g., data entry status, query resolution, and aging) and determine appropriate actions with the study team.

• Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.

• Participate in User Acceptance Testing (UAT) and Quality Control (QC) as needed.

• Collaborate with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import Guidelines.

• Assist with training sites and third-party vendors on CDM-related topics.

• Provide data review training and guidance to Senior Clinical Data Coordinators supporting the trials.

• Perform data review and discrepancy resolution as needed.

• Archive trials and associated documentation upon completion.

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Qualifications

• Minimum of 4-6 years of data management experience, with 2-3 years of leading studies independently preferred.

• Experience from startup through database lock, with at least 2-3 startups and 2-3 database locks.

• Experience with Oracle Inc.'s Inform EDC system is preferred.

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

• Project management experience within Data Management is preferred.

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

• Bachelor’s degree but individuals with commensurate experience will be considered.

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

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com