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开发创突破性新药造福病患


Position:

 

Clinical Operations Director

 

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, regulatory, CMC, HR and finance.

         Implement and drive resource strategy for Clinical Operations to meet project deliverables and timelines and changing workloads.

         Be accountable for department SOP development as well as renewal.

         Support the organization of appropriate training programs.

         Provide management coaching to the staff.

         Be accountable in the country for strategy related to Clinical Operations activities including but not limited to, feasibility, allocations, recruitment enablers, trial execution and local customer relationships related to Clinical Operations(Performs management to 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). 

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

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

 

Your Skillset

         Minimum of 10 years experience in clinical research and 3-4 years middle management experience in related fields such as clinical operations.(Minimum 5 years of monitoring experience in clinical research)

         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

         Strong leadership and influencing skills across geographies and culture differences

         Advanced ability to problem-solve and conflict resolution.

         Operational expertise in risk management and contingency planning.

         Proven ability to manage budgets and resource.

         Experience in international CROs preferred

         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!