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共同打造一流医药研发企业

开发创突破性新药造福病患


Position:

 

Clinical Operations Lead

 

Your Key Accountabilities

         Perform overall management for assigned projects to ensure timely delivery, data quality and budget within control.

- Maintain good communications and relationships with 3rd party vendors, including but not limited to CRC, CRA, PM or DM/Stats if applicable. 

- Lead internal cross-functional communication to get there, including but not limited to medical, regulatory, CMC, and finance.

- Ensure the clinical trials conduction in compliance with ICH – GCP guidelines, local regulatory requirements, SOPs and protocols.

- Be accountable for project budget preparation, overall tracking of Clinical Trial expenditures and negotiating budgets with 3rd party vendors & investigational sites if applicable.

- Be accountable for overall coordination in project audit & Inspection and ensure complete resolution and closure of relevant findings.

         Assess project process and initiate improvement as necessary.

         Provide inputs into SOP development & renewal.

         Apply industry best practices to the execution of clinical trials to improve time and resource efficiency.

 

 

Your Skillset

        Minimum of 6 years of previous Clinical Operations experience with at least 2-3 years of project management experience or equivalent.

        Educated to degree level (biological science, pharmacy or other health related discipline).

        Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

        Clear and compelling communication.

        Effective at problem solving and conflict resolution.

        Operational expertise in risk management and contingency planning.

        Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available).

        Competent in reading/written English is must. 

 

Our Offer:

We offer you an open biotech culture, an exciting journey throughout the world of drug clinical research and development. You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific and management skills, and entrepreneur competency. You can also look forward to a flexible working environment, a pleasant and homelike atmosphere as well as competitive incentive package. If you are looking for a big stage for your profession or beyond, if you are willing to walk out of your “comfortable zone” in your career, come and join us!