System Owner (Assoc. Director, Global Clinical Solutions)

<p>Location: Warsaw, Poland<br/>Hybrid model of work: 3 days in office, 2 remote per week<br/>Please expect it might be fast paced recruitment process</p><p></p><p><span><span>Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the </span><span>BioPharmaceuticals</span><span> R&amp;D organisation, owning and providing industry </span><span>leading technology</span><span> and services on behalf of Development Operations and its internal and external Partnerships.  </span></span><span> </span></p><p><span><span>  </span></span><span> </span></p><p><span><span>The</span></span><b><span> System Owner</span></b><span><span> </span><span>(SO) </span><span>is a member of Global Clinical Solutions, Technology department </span><span>a</span><span>nd is </span><span>end-to-end </span><span>accountable</span><span> for the leadership, lifecycle management and continuous improvement of </span><span>Clinical </span><span>systems as assigned. </span><span>The</span><span> </span><span>S</span><span>ystem </span><span>O</span><span>wner </span><span>can</span><span> cover </span><span>one or more</span><span> systems in the Clinical space.</span></span><span> </span></p><p><span> </span></p><p><span><span>The System Owner works</span><span> closely with </span><span>vendor(s) if applicable, R&amp;D IT</span><span> (Information Technology),</span><span> </span><span>Functional Process Owners, Business Process Management Office (BPMO)</span><span>, </span><span>internal and external customers and stakeholders to ensure customer needs are met and to enable </span><span>optimal</span><span> end-to-end delivery of clinical studies</span><span>. R</span><span>esponsible for the identification, </span><span>definition</span><span> and delivery of improvements in end-to-end clinical study delivery, utilising </span><span>tools</span><span> and techniques to achieve continuous improvement and value creation</span><span> (i.e. </span><span>Lean Six Sigma</span><span>).</span></span><span> </span></p><p><span> </span></p><p><span><span>The SO ensures that the </span><span>S</span><span>ystem meets ICH/</span><span>GxP</span><span> requirements and </span><span>aligns with industry direction, standards, and best practices</span><span>. </span></span><span> </span></p><p><span> </span></p><p><span><span>The System Owner </span><span>r</span><span>epresents</span><span> the </span><span>business interests i</span><span>n strategy discussions and </span><span>provides</span><span> strategic advice to the </span><span>Governance</span><span> team</span><span> in securing long-term business success of their assigned system(s). </span><span>Reviews and approves (if acceptable) </span><span>identified</span><span> system</span><span> risks and mitigations</span><span>. </span><span>Controls and prioritizes all business requests, such as those for feature enhancements, ensuring </span><span>prioritization takes place so</span><span> resources (staff</span><span>, vendor budget</span><span>) are spent on value</span><span>-add activities. Accountable for </span><span>communication </span><span>to</span><span> key stakeholders and the business </span><span>regarding</span><span> the</span><span> </span><span>system</span><span> </span><span>(major </span><span>incidents</span><span>, new releases, etc.)</span></span><span> </span></p><p><span> </span></p><p><span><span>All </span><span>System Owners</span><span> </span><span>will lead</span><span> and manage</span><span> improvement projects as needed</span><span>,</span><span> and will contribute to functional</span><span>, </span><span>regional </span><span>and or global </span><span>initiatives.</span></span><span> </span></p><p></p><p></p><p></p><p><b><span>Typical Accountabilities</span></b><span> </span></p><p><b><span>1) </span><span>System </span><span>Ownership:</span></b><span><span> </span></span><br/><span><span>As the </span><span>allocated</span><span> owner for a specific </span><span>clinical computerized system</span><span>:</span></span><span> </span></p><ul><li><p><span><span>Accountable</span><span> for the design, development, implementation, maintenance, continuous </span><span>improvement</span><span> and ongoing customer support</span><span> for the </span><span>allocated</span><span> area</span></span><span> </span></p></li><li><p><span><span>Accountable</span><span> for</span><span> lifecycle management of all procedural or system documents within the </span><span>allocated</span><span> area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies</span></span><span> </span></p></li><li><p><span><span>Plan</span><span>s</span><span> and prioritize</span><span>s</span><span> product feature backlog and development for the product</span></span><span> </span></p></li><li><p><span><span>Define</span><span>s</span><span> </span><span>system</span><span> vision, </span><span>road-