Project Manager, Early Phase
Auto Import<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><b><u>Key Accountabilities</u>:</b></p><p></p><p><b>Communication and Sponsor Liaison</b></p><ul><li>Own the sponsor relationship and manage sponsor communication.</li><li>Serve as the central point of contact and escalation for functional teams.</li><li>Proactively communicate project progress, risks, and solutions to sponsors and internal teams.</li><li>Lead regular meetings with sponsors and project teams to ensure objectives are met.</li></ul><p></p><p><b>Pre-award Activities</b></p><ul><li>Review relevant materials and attend strategy meetings.</li><li>Prepare for Bid Defense and develop project management strategies.</li><li>Attend Bid Defense and handover meetings.</li></ul><p></p><p><b>Project Planning & Initiation</b></p><ul><li>Manage study start-up activities and ensure best practices are implemented.</li><li>Oversee site selection strategy and review project contracts and budgets.</li><li>Set up project teams and systems, and manage IRB/EC and RA approval processes.</li><li>Lead internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations.</li></ul><p></p><p><b>Project Implementation, Control & Evaluation</b></p><ul><li>Lead projects to completion within budget and schedule, ensuring contract specifications are met.</li><li>Provide performance feedback and ensure project tracking using CTMS.</li><li>Monitor study timelines, recruitment, retention, and data cleaning.</li><li>Prepare for audits/inspections and manage project budgets.</li></ul><p></p><p><b>Project Close-out</b></p><ul><li>Oversee administrative closeout procedures and ensure project documentation is archived.</li><li>Lead end-of-study meetings to document lessons learned.</li></ul><p></p><p><b>Risk Management</b></p><ul><li>Identify potential project risks and implement contingency plans.</li><li>Mitigate risks and keep clients informed throughout the study life cycle.</li></ul><p></p><p><b>Administrative Tasks</b></p><ul><li>Contribute to SOP development and provide oversight and training to Associate PMs and Project Assistants.</li></ul><p></p><p><b><u>Skills</u>:</b></p><ul><li>Leadership skills to lead virtual teams across locations and cultures.</li><li>Negotiation and influence skills to achieve results.</li><li>Decision-making skills in ambiguous situations.</li><li>Problem-solving and root cause analysis skills.</li><li>Excellent interpersonal, oral, and written communication skills.</li><li>Time management and organizational skills.</li><li>Strategic thinking and financial management skills.</li></ul><p></p><p><b><u>Knowledge and Experience</u>:</b></p><ul><li>2 years of Project Management experience with Parexel or 3 to 5 years in related fields.</li><li>Experience as a Functional Team Leader or in coordinating clinical trials.</li><li>Knowledge of ICH-GCP and pharmaceutical industry regulations.</li><li>Proficiency in MS-Office products.</li></ul><p></p><p><u><b>Education</b></u><b>:</b></p><ul><li>Bachelor’s degree in a science-related field or equivalent work experience.</li><li>Advanced degree preferred.</li><li>Additional business degree or PMP certification is an advantage.</li><li><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Scientific/Medical/Pharmacology</span> background is an advantage.</li></ul>