Clinical Project Manager

**When our values align, there's no limit to what we can achieve.**   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. 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. **Key Accountabilities:** **Study Management** * Forecast timelines, budget & FTE resource ( if applicable). * Take a key leadership role in the management of studies’ timeline, quality, cost. * Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations. * Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track. * Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured . * Timely update projects information to the Brand Team. * Review and approve project relevant documents. * Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.) * Prepare and lead investigator and monitor meeting. * Ensure AEs/SAE reporting according to GCP and regulation. * Plan and lead activities associated with study level Quality Control plan. * Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate. * Provide operational support to the ESR investigators to ensure the on time delivery of ESR **Compliance with Parexel standards** * Comply with required training curriculum. * Complete timesheets accurately as required. * Submit expense reports as required. * Update CV as required. * Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements. **Skills:** * Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out * Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization * Leadership skills * Excellent process, SOP, GCP and company policy competency, and drug regulations * Good computer skills in Microsoft and other software. * Fluent in both oral and written English *  Proven ability to deliver training **Knowledge and Experience:** * Minimum 2-3 year experience of project management experience. * Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development * Read, write, and speak fluent English; fluent in host country language required. * undefined * undefined**Education**:Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background