When our values align, there's no limit to what we can achieve. 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, Power Point 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
Free
Project Manager - Early Phase, Shanghai
China, 上海, 上海,
发表 October 31, 2024
描述
联系雇主
雇主信息
PAREXEL International is a leading global biopharmaceutical services provider, which continues to be a premier, trusted partner to clients who rely on the Company for expertise and flexibility, as well as the efficiencies of a worldwide infrastructure, to help them more quickly achieve their development and commercialization goals. For 30 years, PAREXEL has complemented client organizations with strategic insight, deep scientific knowledge, tactical expertise, and a wealth of experience throughout the development process. The Company's offerings include worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and integrated commercialization services. PAREXEL is focused on providing tailored solutions that match a client's specific needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality needed to help them bring safe and effective treatments to patients sooner.
Headquartered near Boston, Massachusetts, PAREXEL operates in over 70 locations throughout more than 50 countries, and has over 11,000 employees worldwide.
Visit www.PAREXEL.com for more information.
Specialties
Regulatory and product development consulting,
early phase clinical research,
phase II-III clinical research,
late phase clinical research,
eClinical solutions,
patient and site recruitment,
clinical logistics,
flexible outsourcing models,
strategic partnering