At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The purpose of the Sr. Manager of Clinical Operation Excellence role is to lead the Clinical Operation Excellence team providing centralized and practicable solutions to the clinical research execution at site level across therapeutic area. This role is expected to enhance the effectiveness of Clinical Operation organization on the aspects including process implementation and optimization, bridge local practice with global initiatives, enables clinical operation excellence in China adherence to regulation, compliance, finance and quality requirements.
1. Manage local process through close collaboration with cross functions at local, regional and global such as Trial Capability, Site Engagement, Design Hub, Clinical Development and Quality team, including the processes of site selection and initiation, JOV, SSU, Country and site feasibility, CDOS, Investigational Products Management at site level etc.
2.Buildup HGRAC management capability within the Clinical Operation function that helps organization on regulation interpretation, process development, operation effectiveness and compliance.
3.Deliver site and vendor contract and payment in a compliance way that support the accelerated site initiation and smooth contract amendment and payment during trial execution.
4.Manage the training compliance relevant to local process.
5.Work with cross function team to proceed vendor sourcing process that meet Clinical Operation deliveries requirements, including but not limit to CTSS service, trial equipment leasing and calibration, printing, translation, third party quality check, recruitment referral.
6.Ensure system management capability within the capability team and even Clinical Operation functions, including but not limited to SAP, CHIEF, IMPACT, eTMF, CT-WIN, CDE Clinical Trial Registry.
1. Act as line manager of the Clin Ops support team, including PM process, succession planning, Merit process. In collaboration with Clinical Operation Director.
2. Responsible for staff recruitment, development and retention- according to affiliate and Clinical Development Organization objectives, leverage diversity of our people and collaborators to thrive in a networked environment.
3.Take a proactive approach to identify the risk or opportunity for the Clinical Operation organization, lead the initiatives to develop or optimize the process that address the issues, lead to more effective organization.
4. Develop team culture of inclusion, innovation, delivery and acceleration.
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