Study Start Up Specialist - Senior - Spain - FSP

<p><b>When our values align, there's no limit to what we can achieve.</b><br/> <br/>At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p>If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then <b><span>Parexel FSP</span></b> challenges you to live up to your potential by joining us at <b>SSU Specialist Senior</b>, home-based and sponsor dedicated, in <b><span>Spain</span></b>.</p><p></p><p>The Senior Study Start-up Specialist is responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Manager and c<span>ontributes to change initiatives across the SSU department.  </span>May have Line management/mentoring responsibilities for SSU Specialist.</p><p></p><p>We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.</p><p>As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.</p><p></p><p><b><span>The most significant aspect of this position is</span></b></p><ul><li>Collation and tracking of site feasibility.</li><li>Responsible for ensuring CDA is in place.</li><li>Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information for other related organizations, for the assigned country eg IRAS</li><li>Responsible for ensuring clinical trial insurance is in place for submission.</li><li>Responsible for the translation and co-ordination of translations for documents required for submission.</li><li>Creation, review, and customization of country/site specific Informed Consent Forms (ICFs)</li><li>Works with regulatory team members and SSU Lead to secure authorization of regulatory documents.</li><li>Works with legal, contract vendor and SSU Lead to secure authorization of contracts.</li><li>Collects and reviews initial regulatory packets and site contracts for investigator sites.</li><li>Coordinate efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review, and approval of essential documents for IP Release</li><li>Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines.</li><li>Ensures all relevant documents are submitted to the Trial Master File (TMF)</li><li>Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up.</li><li>Inform team members of completion of regulatory and contractual documents for individual sites.</li><li>Attend project meetings with cross functional department leads to provide updates.</li><li>Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.</li><li>Escalate risks (e.g. timelines, etc.) to SSU Lead or CTM, as appropriate.</li><li>Reviews and provide feedback to SSU Lead on site performance metrics.</li><li>Maintains and manages SSU data tracking entries, reviews for completeness and accuracy.</li><li>Facilitates process improvement efforts both within the department and in cooperation with other departments.</li><li>Support the creation and development of start-up plans and essential document checklists.<br/> </li></ul><p><b><span>From you we expect</span></b></p><ul><li>Bachelor’s Degree or 3 -5 years’ relevant experience, including 2 years of regulatory &amp; study-start up experience or other relevant experience; or equivalent combination of education, training, and experience.</li><li>Pharmaceutical or related industry experience</li><li>Previous experience of working in a Start-up team,</li><li>Experience of in-house trials/process design</li><li>Excellent knowledge of GCP and regulations</li><li>Contribute to training within SSU and update SOPs/WI</li><li>Ability to work independently in a fast-paced environment.</li><li>Strong problem-solving skills</li><li>Ability to mentor, lead and motivate more junior staff</li></ul><p></p><p>For an immediate interview, ple