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 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.

Purpose

The purpose of the Sr. Manager/Lead-Clinical Laboratory Operations role is to serve a pivotal role in clinical trial initiation and execution, and to provide technical， process and logistic support as it relates to management of laboratory, ECG, imaging, storage, DNA banking, IHC, and other diagnostic support for clinical trials world-wide. The Sr. Manager-Clinical Laboratory Operations coordinates vendor activities for assigned trials as well as facilitating research relating to laboratory, ECG, imaging, storage, DNA banking, IHC, and other diagnostic issues that arise during clinical trials. The Sr. Manager-Clinical Laboratory Operations also partners with CPM, medical staff and other functions to provide input to protocol development/design, develop and implement the integrated trial laboratory plans and the review and monitoring of resultant data, ultimately providing high quality, combinable data in a cost effective and timely fashion.

The Sr. Manager/Lead-Clinical Laboratory Operations roles maybe divided into study team support directly working with compounds and clinical studies or a combination of study work and subject matter expert responsibilities ensuring departmental inclusion in cross-functional initiatives and operations.

The Sr. Manager/Lead-Clinical Laboratory Operations located in China works closely with global CLS Teams to support China registration studies in partnership with other affiliate staff. This role also works within the global CLS Teams to implement processes and develop Third Party relationships to support the growing portfolio.

Primary Responsibilities

Communication/Information Management

• Assist medical staff in protocol development.
• Provide complete laboratory, ECG, imaging, sample banking, storage and other diagnostic support as listed above for assigned compound(s).
• Provide expertise and consultation relating to laboratory, ECG, imaging, sample banking, storage and other diagnostic biomarkers, including assay development and validation.
• Provide technical and logistical consultation regarding laboratory, ECG, imaging， sample banking, storage and other diagnostic biomarker issues and services.
• Prepare the integrated laboratory plan for the trial incorporating feedback from other functions. Ensure feasibility and accurate costing of this plan and provide to CPM.
• Partner with the Sourcing organization to ensure outsourced work is correctly specified to vendors.
• Contribute to vendor oversight process.
• Monitor for data errors and vendor transmission issues.
• May participate in training (Affiliate, Investigator, Study Coordinators, CRO, etc.) regarding laboratory, ECG, imaging, sample banking, storage and other diagnostic services.
• Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to Sr. Manager/Lead-Clinical Laboratory Operations deliverables.
• Provide metrics as requested.
• Ensure customers understand Sr. Manager/Lead-Clinical Laboratory Operations roles and responsibilities.
  
  
  

Process Application and Improvement

• Participate in functional and cross-functional process improvement initiatives.
• Work to improve existing processes and to implement new processes in an efficient manner.
  
  
  

Self-Improvement

• Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirement.
• Participate fully in performance management process.
  
  
  

China Focus

• Drive the collaboration with CLS Teams to ensure the growing of China portfolio independently.
• Proactively lead the communication with CLS Teams in the exploration of local Third Party and provide inputs based on local needs and expectation.
• Assist in China strategy discussion based on technical expertise and understanding of local reality of diagnostic support.
  
  
  

Transferred Skills

• Requires comprehensive business and technical knowledge/experience to improve products, processes, and services.
• Makes decisions that impact a range of standard and non- standard operational， process, project, or service activities.
• Serves as a key resource within a business area or discipline.
• Gains support for ideas or positions on difficult issues.
• Anticipates and resolves complex problems.
• Drives solutions for products, processes, and services across a large business area.
• May lead medium-scale projects or programs with moderate risks and resource/financial requirements.
• May manage budgets for medium-size projects or programs.
• Establishes key relationships with those outside of business area.
• Identifies internal and external customer requirements and develops solutions to meet customers' needs.
  
  
  

Minimum Qualification Requirements

• Bachelor’s degree in a scientific/life science fiddle and around 5 years relevant working experience.
  
  
  

Other Information/Additional Preferences

• Knowledge of clinical drug development
• Strong self-management skills
• Strong teamwork and interpersonal skills
• Strong communication skills (verbal and written)
• Conceptual understanding of information technology
• Strong organizational skills
• Negotiation skills
• Detail oriented
• Ability to handle multiple projects with multiple parties at one time
• Medical technology knowledge and experience is preferred
• Clinical trial experience preferred
  
  
  

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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