Data Team Lead

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

Essential Functions

• Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, 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.
• Work 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.
• Provide data review training and guidance to Sr. Clinical Data Coordinators supporting their trial(s).
• Perform data review and discrepancy resolution, as needed.
• Archive trial(s) and associated documentation upon trial(s) completion.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Qualifications:

• Minimum of 5 years of data management experience required.
• Bachelor's degree or certification in a related allied health profession from an accredited institution (e.g., RN, MT, PA, RT) preferred; candidates with equivalent experience will be considered.
• Experience with Electronic Data Capture (EDC) systems required.
• Experience with Oracle Inc.'s Inform EDC system preferred.
• Experience in Oncology and/or inflammatory therapeutic areas preferred.
• Project management experience within Data Management preferred.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management preferred.

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