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      简体中文
      欢迎加入来凯医药

      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!



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