Clinical Data Manager – FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Serve as the key data management representative on interdisciplinary project teams, ensuring effective communication flow.

• Share essential clinical data management metrics and identify suitable actions with the study team.

• Review, create, and draft clinical trial documentation and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.

• Engage in User Acceptance Testing and Quality Control as necessary.

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

• Support site and third-party vendor training on clinical data management subjects.

• Offer data review training and mentorship to Senior Clinical Data Coordinators.

• Conduct data review and address discrepancies as required.

• Archive completed trials and relevant documentation.

• Ensure compliance with Good Clinical Practice and applicable local and international regulations.

⛳️ Requirements

• At least 5 years of experience in data management.

• A Bachelor's degree or certification in a related allied health field from a recognized institution is preferred; equivalent experience will be considered.

• Experience with Oracle Inform EDC.

• Preferred experience in oncology and/or inflammatory therapeutic areas.

• Project management experience within Data Management is preferred.

• Experience in data management within a CRO or Pharma setting.

• This role is not eligible for UK visa sponsorship.

• Clinical trial experience in line with ICH/Good Clinical Practices and relevant procedures and guidelines.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.