Clinical Data Manager

Overview

As Clinical Data Manager in Safety Assessment, you will oversee complex trial data across multiple projects, ensuring timely, accurate reporting aligned with CDISC SDTM standards. You will work remotely within the UK, coordinating with sponsors and internal teams to manage data life cycles and regulatory compliance. Your role focuses on data quality, transfer governance, and mentoring peers to uphold high standards. This position offers meaningful impact by advancing drug safety data for life-saving therapies.

Pay / Benefits

• up to 40,000/annum
• bonus
• benefits
• remote work within UK

Responsibilities

• Gather sponsor requirements for data transfer frequency and dataset architecture
• Prepare and review Data Transfer Agreements for various data types
• Oversee SDTM and non-SDTM dataset preparation for clinical studies
• Quality control across regulatory compliance, data corrections, and programming specifications
• Ensure datasets are prepared and transferred to sponsors per regulations
• Support peers with secondary document review and QC
• Transfer datasets via internal or external data portals
• Manage workloads across studies with priority timelines
• Mentor and train staff, develop data templates and tools
• Draft or update SOPs and procedural documents
• Serve as team lead or support supervisor with scheduling and administrative tasks
• Perform other duties as assigned

Key requirements

• Bachelor’s degree in Life Sciences
• Knowledge of CDISC CDASH, SDTM, and Controlled Terminology
• Significant experience in a similar clinical data management role in CRO or pharmaceutical environments
• Excellent communication with internal/external stakeholders
• Familiarity with data formats: .xml, .xpt, sas7bdat, ASCII, .DAT, .xlsx
• Knowledge of Microsoft Office Suite
• Strong organizational skills and ability to meet deadlines
• Excellent written and verbal communication, leadership and negotiation skills
• Ability to interact with clients and all levels of employees while supporting teams

• strong communication
• leadership
• negotiation
• CDISC CDASH
• CDISC SDTM
• Controlled Terminology Standards

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