Clinical Project 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><span><b><u>Key Accountabilities:</u></b> </span></p><p><span> </span></p><p><span><b><u>Study Management</u></b> </span></p><ul><li><p><span>Forecast timelines, budget &amp; FTE resource ( if applicable). </span></p></li></ul><ul><li><p><span>Take a key leadership role in the management of studies’ timeline, quality, cost. </span></p></li></ul><ul><li><p><span>Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations.  </span></p></li></ul><ul><li><p><span>Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track.  </span></p></li></ul><ul><li><p><span>Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global &amp; regional team to ensure up-to-date information captured .  </span></p></li></ul><ul><li><p><span> Timely update projects information to the Brand Team.  </span></p></li></ul><ul><li><p><span>Review and approve project relevant documents.  </span></p></li></ul><ul><li><p><span>Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.)  </span></p></li></ul><ul><li><p><span>Prepare and lead investigator and monitor meeting.  </span></p></li></ul><ul><li><p><span>Ensure AEs/SAE reporting according to GCP and regulation.  </span></p></li></ul><ul><li><p><span>Plan and lead activities associated with study level Quality Control plan.  </span></p></li></ul><ul><li><p><span>Develop &amp; manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate.  </span></p></li></ul><ul><li><p><span>Provide operational support to the ESR investigators to ensure the on time delivery of ESR </span></p></li></ul><p><span> </span></p><p><span><b><u>Compliance with Parexel standards</u></b> </span></p><ul><li><p><span>Comply with required training curriculum.  </span></p></li></ul><ul><li><p><span>Complete timesheets accurately as required.  </span></p></li></ul><ul><li><p><span> Submit expense reports as required.  </span></p></li></ul><ul><li><p><span>Update CV as required.  </span></p></li></ul><ul><li><p><span>Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements. </span></p></li></ul><p><span> </span></p><p><span><b><u>Skills</u></b>:  </span></p><ul><li><p><span>Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out  </span></p></li></ul><ul><li><p><span>Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization  </span></p></li></ul><ul><li><p><span>Leadership skills  </span></p></li></ul><ul><li><p><span>Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software.  </span></p></li></ul><ul><li><p><span>Fluent in both oral and written English  </span></p></li></ul><ul><li><p><span>Proven ability to deliver training </span></p></li></ul><p><span> </span></p><p><span><b><u>Knowledge and Experience</u></b>:  </span></p><ul><li><p><span>Minimum 2–3-year experience of project management experience.  </span></p></li></ul><ul><li><p><span>Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development  </span></p></li></ul><ul><li><p><span>Read, write, and speak fluent English; fluent in host country language required. </span></p></li></ul><p><span> </span></p><p><span><b><u>Education</u></b>:  </span></p><ul><li><p><span>Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background </span></p></li></ul><p><span> </span></p>