Project Manager - EP
China, Remote Additional Locations: Australia, Remote 求人ID R0000029818 Category Project LeadershipAbout this Role
***Mandarin language is requested.
Job Purpose:
- Project Manager for Phase I and II studies
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
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