Principal, Evidence Generation Data Management (m/f/x)
Ort
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Rahmendaten
<p>Principal, Evidence Generation Data Management (m/f/x)</p> <hr> <h3><strong>Project Description:</strong></h3> <p>The project focuses on the development and implementation of a strategy for Risk-Based Quality Management (RBQM) and the optimization of associated technologies, processes, and standards. The role involves consulting, knowledge transfer, and technical leadership to support data management in clinical research studies.</p> <hr> <h3><strong>Framework Conditions:</strong></h3> <ul> <li><strong>Start Date:</strong> 02 June 2025 <li><strong>Project End:</strong> 31 May 2026 <li><strong>Working Hours:</strong> 40 hours per week <li><strong>Remote Work:</strong> 100% <li><strong>Travel:</strong> Not specified; possibly within the EU <li><strong>Contract Extension:</strong> Possible </ul> <hr> <h3><strong>Tasks:</strong></h3> <ul> <li> <p>Develop an RBQM implementation strategy and optimize RBQM-related technologies, processes, and standards</p> <li> <p>Provide consulting and know-how transfer to Department Leads in the development of the RBQM strategy</p> <li> <p>Ensure end-to-end delivery of data management services for assigned studies or projects</p> <li> <p>Provide technical guidance to CROs and third-party vendors to ensure high-quality, timely, and cost-effective deliverables</p> <li> <p>Manage data management activities for assigned studies, including study set-up, conduct, and close-out</p> <li> <p>Deliver on-time and on-budget Data Management outputs, including:</p> <ul> <li> <p>Data Management Plan</p> <li> <p>Database specifications and build</p> <li> <p>Interim data cuts</p> <li> <p>Database lock</p> <li> <p>Study archiving</p> </ul> <li> <p>Lead RBQM initiatives, integrate external industry knowledge, and implement innovative best practices</p> </ul> <hr> <h3><strong>Requirements:</strong></h3> <ul> <li> <p>Excellent command of English (oral and written)</p> <li> <p>Strong knowledge of RBQM concepts and proven experience in RBQM implementation, ideally in a leading role</p> <li> <p>Solid understanding of data integrity principles and GDPR compliance</p> <li> <p>Technical proficiency in working with data from CROs and third-party vendors</p> <li> <p>Proven skills in continuous improvement, project management, change management, and risk management</p> <li> <p>Demonstrated expertise in study design, conduct, and execution</p> <li> <p>In-depth knowledge of clinical research principles, concepts, methods, and standards</p> <li> <p>Strong communication skills with the ability to clearly explain complex concepts in simple terms</p> </ul>