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.

The purpose of the Sr. Manager, Clinical Lab, Diagnostic and Imaging Partnership (CLDIP) Team 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, device, imaging, storage, DNA banking, IHC, and other diagnostic support for clinical trials world-wide.

The CLDIP Sr. Manager coordinates vendor activities for assigned trials as well as facilitating research relating to laboratory, device, imaging, storage, DNA banking, IHC, and other diagnostic issues that arise during clinical trials.

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

Key Responsibilities

1.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, device, imaging, sample banking, storage and other diagnostic biomarkers, including assay development and validation.

Provide technical and logistical consultation regarding laboratory, device, 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.

Support regulatory activities related to NMPA, HGRAC, Customs, etc.

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 CLO deliverables.

Provide metrics as requested

Ensure customers understand CLO roles and responsibilities.

2. 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.

3. Self-Improvement

Maintain compliance with all departmental, Medical Quality System(MQS) and Lilly Research Laboratory(LRL) training requirements.

Participate fully in performance management process

4.China Focus

Drive the collaboration with CLO Teams to ensure the growing of China portfolio independently.

Proactively lead the communication with CLO 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.

Transferrable 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 field and around 5 year 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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