Note: The job is a remote job and is open to candidates in USA. ProPharma provides consulting solutions across the pharmaceutical, biotechnology, medical device, and clinical research industries to support the development and lifecycle management of healthcare products. The Clinical Data Manager supports Phase I–III clinical trials by managing clinical data activities, ensuring data quality, regulatory compliance, timely delivery, and effective collaboration with study teams and vendors.
Responsibilities
- Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange
- Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and a1ging, etc.) and determining appropriate actions in conjunction with study team
- Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines
- Participate in User Acceptance Testing (UAT), as needed
- Participate in Quality Control (QC), as needed
- Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines
- Assist with site and/or third party vendor training on CDM-related topics
- Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s)
- Perform data review and discrepancy resolution, as needed
- Responsible for archiving trial(s) and associated documentation upon trial(s) completion
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations
Skills
- Minimum of 5 years of data management experience is required
- Experience with Electronic Data Capture (EDC) system(s) is required
- Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered
- 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
- Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred
Benefits
- Remote working is supported.
- New hires based within a reasonably short commute of one of ProPharma's offices are encouraged to work on a hybrid basis, spending some time working from that office location as agreed with their manager.
- A workplace committed to diversity, equity, and inclusion.
- A safe space where employees feel empowered to succeed.
Company Overview
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