Clinical Data Manager FSP (Homebased UK)

The Clinical Data Manager performs activities pertaining to the conduct of Phase I-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 on time within budget and with highest achievable quality.

Summary of the Essential Functions of the Job

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

Minimum Requirements

• Minimum of 5 years of data management experience
• Bachelors 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.
• Oracle Inform EDC experience
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience (within Data Management) is preferred.
• CRO or Pharma data management experience

This role is not eligible for UK visa sponsorship

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