<p><b>When our values align, there's no limit to what we can achieve.</b><br><br>At <a href="https://himalayas.app/companies/parexel">Parexel</a>, 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 <a href="https://himalayas.app/companies/parexel">Parexel</a>, 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><b><a href="https://himalayas.app/companies/parexel">Parexel</a> FSP </b>is looking for <b>Regional Site Start Up II </b>to join our team in <b>Canada.</b></p><h3>Job Summary</h3><p>The <b>Regional Site Start Up (SSU)</b> role is responsible for leading and delivering site start-up and activation activities across clinical trials. This role will ensure timely site activation, maintain strong relationships with sites, and work cross-functionally with internal and external teams to efficiently achieve study site activation timelines. The role provides regional expertise, ensuring large areas of geographic-specific needs are addressed and adherence to study milestone timelines. This role must possess excellent interpersonal skills, attention to detail, and the ability to collaborate across teams to ensure timelines are achieved.</p><h3>CORE JOB RESPONSIBILITIES:</h3><h3><u>Site Start Up and Activation:</u></h3><ul><li><p>Accountable to delivering individual site activation timelines to plan for assigned sites </p></li></ul><ul><li><p>Gather, organize and share, as appropriate, all required essential documents from clinical sites and Sponsor specific documents to ensure compliance with Regulatory and Sponsor requirements as part of the site activation process </p></li></ul><ul><li><p>Collect site intelligence to inform site discussions and maintain site information in CTMS </p></li></ul><ul><li><p>Ensure site regulatory packages meet country requirements, TMF standards and ICH-GCP compliance </p></li></ul><ul><li><p>Assist with reviewing Informed Consent Forms (ICF) as requested </p></li></ul><ul><li><p>Facilitate the translation of Essential Documents that may be required in languages other than English for purposes of submission to and approval from Regulatory Health Authorities and/or Independent Review Board/Ethics Committees </p></li></ul><ul><li><p>Provide regional expertise, addressing specific geographic challenges to facilitate site activation. Serve as the primary point of contact and escalation point for sites: troubleshoot issues and provide strategic solutions to ensure activation timelines are achieved </p></li></ul><ul><li><p>Update trackers with key study information, risks and mitigation strategies </p></li></ul><ul><li><p>Ensure all site start-up documents are fi