Freelance Lead Clinical Data Manager

A Freelance Lead Clinical Data Manager is required for an initial 6 month contract with a global CRO. 

WHAT YOU WILL BE DOING

• Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure.
• Develop or quality control review Data Validation Specifications (DVS) documents. Program edit checks and other system functions within EDC as needed. Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.
• Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans. Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.).
• Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation
• Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation

WHAT YOU CAN BRING TO THE ROLE

• Comprehensive experience in Clinical Data Management
• 2+ years of experience in leading project teams
• Certifications and/or courses completed in Medidata Rave Study Design and Build Essentials strongly preferred
• Detailed understanding of project planning and management methods
• Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes

WHAT YOU GET IN RETURN

• The opportunity to lead project teams
• Excellent hourly rates
• Flexible remote working

WHAT TO DO NEXT

• Please apply now with an updated CV

trish@warmanobrien.com / + 44 (0) 7766 571707