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
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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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