<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>The Clinical Trial Operations Specialist (CTOS) is a key member of Clinical Delivery Team accountable for clinical trial execution excellence including any of the following: planning, coordination, and conduct of complex, regulatorily defined tasks; seamless trial operation and communication to all applicable stakeholders; timely delivery of all materials, documentation and information needed to setup, execute and deliver assigned trial (s), and oversight of trial supplies, submissions, and other operational parameters.</p><h3>Key Accountabilities:</h3><h3><u>Clinical Trial Operations </u></h3><ul><li>Accountable for the planning, coordination, and conduct of trial activities according to ICH-GCP </li> <li>Assures the seamless conduct of trials within defined timelines in close coordination and communication with the Clinical Trial Leader (CTL) </li> <li>Collaborate and interact with other core and extended trial team members, Regional Operating Unit (R/OPUs) level functions (e.g. Clinical Trial Manger) and interface functions (i.e. Clinical Trial Supplies Unit, Sourcing, Legal) </li> <li>Ensures cooperation with external functions (i.e. Clinical Research Organizations, advisors, investigators) to conduct clinical trials </li> <li>Independently manage correspondence, complex reports, tracking tools and budget overviews </li> <li>Address and answer complex questions from global and local trial teams and trial sites; mediate decisions under own responsibility </li> <li>Communication, ordering, and tracking of information related to the trial supplies distribution to R/OPUs and support the planning of clinical trial supplies </li> <li>Independently monitor trial progress and perform plausibility checks; implement corrective actions if needed </li> <li>Overview and update of records to address local regulatory demands from Ethics/Authorities to ensure timely submission/re-submission </li> <li>Oversight of all trial related wrap-up activities (i.e. data cleaning) </li> </ul><h3><u>Clinical Trial Documentation </u></h3><ul><li>Preparation, finalization, and archiving of documentation related to clinical trials, in accordance with internal and external regulations and guidance and in adherence to the clinical trial document management process </li> <li>Oversight of the preparation, co