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Purpose:

The purpose of the (Sr.) Quality Oversight and Capability (QOC) Manager role is to provide support to the staff who are engaged in clinical research at the country and site-level.  The role will focus on the scope activities and deliverables that are owned by Clinical Operations function and provide practical tools, training, and consultation on internal business processes and practices that are designed to promote quality and compliant execution of clinical research and delivery of high quality data from sites in China.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. Develop and maintain oversight process for Clinical Operations deliverables

a) Collaborate with cross-functional team to identify and drive adoption of innovative ideas / solutions. Ensures consultation by Clinical Operations on the application of new technology and tools that are selected globally or locally to enable optimal use by investigative sites and/or by patients. 

b) Manage a quality improvement agenda of activities based on internal and external trends.  Develop and lead oversight activities to ensure China processes are in compliance with CDOS and relevant Lilly processes.

c) Identify training needs for the organization based on business needs and trends, collaborate with SMEs to deliver the process training/refresh on a regular basis. Understand global and local processes, evaluate the risk/impact on China clinical operations, and take the lead of local implementation if appropriate.

d) Network with cross-functional teams to onboard new service vendors while business needs evolve, continuous optimizing vendor onboarding to accelerate vendor contract execution with compliance with company policy.

e) Develop team capability in vendor service oversight where required. Partner with study team to provide feedback to vendor for continuous improvement where necessary

f) Ensure system management capability within Clinical Operation functions. Acting as an expert function on system unitization and oversight the system implementation locally with global engagement.

2. Supports the planning and execution of quality activities for China Clinical Operations with internal and external partners

a) Develops and maintains external party management process for China. The Quality Oversight and Capability Manager will maintain process and training in China to be aligned with Global Lilly requirement/commitment and local regulations and ensure the consistency within Clinical Operations.

b) Participates directly in all quality planning activities with internal and external business partners. The QOC Manager will interface with the quality function in any TPOs used by China clinical operations.

c) Incorporates learning from issues management, inspections, and audit findings into materials and processes that improve the quality of clinical research execution at country level and investigator sites.  Ensures that CAPA is effectively implemented in the function through updates to working documents, forms, templates and instructions.

3. Provides expertise and knowledge in the area of regulations and compliance

a) Understands and complies with all regulatory requirements, ICH/GCP, and applicable guidelines

b) Understands and complies with all Ethics & Compliance, Procurement, Legal, Financial, and Global Medical Standards and Procedures

c) Expert in application of regulations and guidelines regarding local study execution practices which include process maps, tools, and resource documents

Minimum Qualification Requirements:

Bachelor’s degree or equivalent work experience in a scientific or health-related fieldMinimum of 3-5 years’ CRA or 2 years’ country study manger or similar position working experience in clinical trialsFluent English communication in reading, writing and spoken formatsStrong self-management and organization skillsProject management skillsStrong problem solving and communication skills (both verbal and written)Good computer Microsoft office software skillsNeed to have some meetings with global team out of working time.

Other Information/Additional Preferences:

Strong analytical skillsProficiency in use of standard Microsoft office softwareRisk management and contingency planning skills/experienceStrong leadership and networking skillsStrategic thinkingSelf-motivated and with good teamwork spirit

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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