Clinical Project Manager (FSP)

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.    Education:   - Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background