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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 Operation Leader

 

Your Key Accountabilities

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

Act as a study team leader  to set up team goals and lead cross-function communication to get there, including but not limited to medical, DM, Statistician, regulatory, CMC, supply chain, legal and finance.
Performs management activities to clinical trials including but not limited to clinical study start up from any stages, budget control, initiation, patient enrollment, protocol adherence, CRF compliance, data quality to meet specified ethical, scientific, regulatory needs. Develop and maintain KOL relationships.

Maintains good communications and relationships with CRO partners, including but not limited to CRC, CRA, PM or DM if applicable.  

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

 

Your Skillset

1.    Minimum 5 years of monitoring experience in clinical research

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

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

4.    clear and compelling communication

5.    Strong leadership and influencing skills across geographies and culture differences

6.    Experience in international CROs preferred

7.    Competent in written and oral English is must

Work independently and think widely as a leader, self-motivated, fast-learner, willing to meet challenges and share responsibilities with partners.

 

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!