Project Manager - Early Phase

Key Accountabilities:

• Initiate, plan, manage and close out of Phase I and II projects with all departments in Parexel including external vendors and Early Phase partner sites.
• Project communication with sponsor, Parexel team and external vendors
• Continuous reporting and update of project progress including communication internally and with sponsor and external vendors as needed.
• Organizing and supporting the submission of Early Phase studies to the China regulatory authority and local Ethics Committee according to ICH-GCP timelines.
• Budget control for Phase I and II studies including:

• Service inquiries with external vendors
• Budget and contract negotiation with sponsors and external vendors
• Forecasting, tracking and invoicing

• Responsible for core team meetings with sponsor, Parexel team and external vendors.
• Routine filing of essential documents and quality control checks of the Trail Master File.
• Compiling and maintaining study documents such as the project plan.
• Support setup of project specific training in Parexel system.

Skills:

• Knowledge in the field of clinical studies
• Organizational talent
• Very good knowledge in English(spoken and written command) and Chinese
• Ability to work under pressure
• Solid computer and internet skills (e.g. MS-Office, Excel, PowerPoint and MS Project)

Knowledge and Experience:

• Relevant experience in project management in a research institute or pharmaceutical industry
• Knowledge of regulations according to ICH/GCP and applicable local regulations
• Budget / Contract experience desirable

Education:

• University degree or equivalent
• Scientific/Medical/Pharmacology background an advantage