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!