Shanghai, Shanghai Municipality
The purpose of the (Senior) Clinical Operations Quality Control Manager role is to provide support to the staff who are engaged in clinical research at the 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 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.
- Develops and maintains quality control processes for Clinical Operations deliverables
- Creates and maintains an integrated, logical view of all quality control mechanisms and processes that impact data quality in China. This could include the development of process diagrams, data flow diagrams, and relationship maps that illustrate how various process, tool, and control mechanisms in the clinical research process are related. These mechanisms include: monitoring plan, risk management plan, data validation plan, medical data review, issues management, and various forms of quality oversight visits to clinical investigator sites.
- Provides tools for Country Study Manager (CSM) and CRAs that provide integrated, real-time views of quality at investigator sites that incorporate data from all sources. The focus of this activity is to ensure that the review of site quality is proactive and better able to identify issues at sites early so that corrective action could be taken more immediately. Examples of data sources include: InForm (eDC), IWRS, Lab systems, CTMS, and JOV/QOV output
- Developes and maintains the template for a data quality control plan. The Clin Ops QC Mgr checks compliance with the data quality control plan which is created by the CSM.
- Provides proactive support for Clinical Operations by implementing continuous improvement mindset
- Incorporates learning from issues management, inspections, and audit findings into materials and processes that improve the quality of clinical research execution at investigator sites. Ensures that CAPA is effectively implemented in the function through updates to working documents, forms, templates and instructions.
- 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. For example this could include electronic Informed Consent Document applications, electronic Clinical Outcomes Assessment devices/applications, and the use emerging technology to support site level patient screening or study drug compliance.
- Manage a quality improvement agenda of activities based internal and external trends and provide support and oversight to China-specific processes (e.g. like HGRAO submissions)
- Supports the planning and execution of quality activities for China Clinical Operations with internal and external partners
- Develops and maintains Joint Oversight Visit (JOV) process for China. The Quality Control Manager will maintain process and training in China to be aligned with Global Lilly requirement/commitment. The QC Manager will ensure that local China requirements ae into JOV practice in China. The QC Manager trains CSMs in the JOV process and maintains master JOV schedule
- Participates directly in all quality planning activities with internal and external business partners. In this capacity the QC Manager serves as the liaison on quality topics to Lilly’s Global function (i.e. Site Engagement) or any future function deemed responsible for the global JOV process. Additionally the QC Manager will interface with the quality function in any TPOs used by China clinical operations.
- The QC Manager may interact with Quality functions in hospitals (e.g. GCP Offices) to coordinate quality expectations between Lilly and the hospital with regard to standard practice.
- Provides expertise and knowledge in the area of regulations and compliance
- Understands and complies with all regulatory requirements, ICH/GCP, and applicable guidelines
- Understands and complies with all Ethics & Compliance, Procurement, Legal, Financial, and Global Medical Standards and Procedures
- Expert in application of regulations and guidelines regarding local study execution practices which include process maps, tools, and resource documents
Basic QualificationsMinimum Qualification Requirements:
- Bachelor’s degree or equivalent work experience in a scientific or health-related field
- Minimum of 3-5 years’ CRA or 2 years’ country study manger or similar position working experience in clinical trials
- Fluent English communication in reading, writing and spoken formats
- Strong self-management and organization skills
- Project management skills
- Strong problem solving and communication skills (both verbal and written)
- Good computer Microsoft office software skills
- Need to travel periodically within China
- Need to have some meetings with global team out of working time.
- Strong analytical skills
- Proficiency in use of standard Microsoft office software
- Risk assessment and contingency planning skills/experience
- Strong leadership and networking skills
- Strategic thinking
- Self-motivated and with good teamwork spirit
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 57310.
Lilly is an EEO/Affirmative Action Employer and 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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