Clinical Trial Manager - FSP

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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&#39;re committed to making a difference.</p><p></p><p></p><p><b><u><span>Key Accountabilities</span></u></b><u><span>:</span></u></p><ul><li>Manage external vendors and contract research organizations</li><li>Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual</li><li>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</li><li>Assist with protocol development and study report completion</li><li>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</li><li>Provide guidance, direction, and management to CRAs</li><li>Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</li><li>Coordinate study supplies</li><li>Negotiate contracts with vendors of clinical trial services</li><li>Review Informed Consent Forms, CRFs, and study related materials</li><li>Plan and participate in investigator meetings</li><li>Assist and support data query process</li><li>Ensures trial master file is current and maintained</li><li><span>Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.</span></li></ul><p></p><p><b><u>Skills:</u></b></p><ul><li>Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.</li><li>Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.</li><li>Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment</li><li>Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders</li></ul><p></p><p><b><u>Knowledge and Experience</u></b>:</p><ul><li>Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)</li><li>Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)</li><li>Experience of data management and query resolution in clinical trials</li><li>Overall knowledge of site management and monitoring procedures</li></ul><p></p><p><b><u>Education:</u></b></p><ul><li>Degree in the life sciences field preferred</li></ul><p></p><p></p>