Associate-Clinical Laboratory Operations

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
March 09 2018
Ref
39672BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
The purpose of the Associate, 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 CLO Associate 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 CLO associate 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 CLO Associate roles may be 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.

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 CLO deliverables
  • Provide metrics as requested
  • Ensure customers understand CLO 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 requirements.
  • Participate fully in performance management process

Company Overview
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 39,000 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.

Basic Qualifications
  • Bachelor's degree in a scientific discipline or related life sciences field.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/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

Additional Information
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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