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 Lilly Professional Apprenticeship Program is a 13-month (fixed duration employee) program for people without a 4-year degree. As a Lilly Professional Apprentice, you will receive a combination of formal training, on-the-job learning, and mentoring in a key functional area to be equipped to compete for a Lilly position after successful completion of the apprenticeship. Upon successful completion of the program, apprentices will have the opportunity to advance their careers, including consideration for full-time positions at Lilly.
Purpose:
The Clinical Laboratory Sciences (CLS) organization is responsible for delivering reliable clinical data that enables our business partners and customers to make informed clinical and healthcare decisions. This requires an in-depth understanding of our clinical labs and data processes; the people that we manage; the functional partners with which we work; the quality standard to which our teams adhere; and the streamlined coordination and communications with our third-party providers.
The purpose of the CLS Specialist is to serve a pivotal role in the creation of a clinical trial laboratory database, tracking of clinical trial samples from the point of collection through testing, ensuring Lilly has received the data generated from those laboratory samples, and assisting in the preparation of study database locks. This position will also provide technical, process and logistical support as it relates to the management of the laboratory database and sample/data tracking. This role requires understanding of CLS processes, central laboratory processes, clinical sample processing, and data lock processes. The CLS Specialist will partner with the CLS Associates, CLS Consultants, CSSP (Labs Connect support), and central laboratories to ensure the databases are set up as expected, and enable tracking of the laboratory samples and data.

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.

• Communication/Information Management
• Manage investigator and study team requests for access to central laboratory vendors’ site portals (during the study start-up process as well as throughout the study) and provide reports to CLAs/teams regarding user access listings
• Maintain a tracker of initial kit shipments to investigator sites and other study start-up reports, as well as investigate questions or issues for ongoing study shipments
• Assist with study start-up processes such as obtaining necessary import of record (IoR) information from the study team and provide proforma invoices as needed
• Utilization of the SMaRT system related to sample tracking from the sites to the testing laboratories as well as the results delivery associated with those clinical trial samples. This includes ensuring the appropriate follow-up occurs when samples or data do not appear to be moving through the system.
• Utilize SMaRT to merge laboratory information from different systems and manual spreadsheets in order to track missing samples and their status
• Create and utilize dashboards to report our metrics to clinical teams and leadership
• Monitor for data errors and vendor transmission issues
• Assess study issues and impact on study timelines
• Prepare and submit laboratory panic/hepatic/toxicity alert emails to the study team and file them within the appropriate CLS location
• Upload study documents into the electronic trial master file (eTMF)
• Review and set-up Protocol Specific Addendum (PSA) for clinical trials (the Associate will approve the PSA), serving as the person who liaises with the CLA, CSSP and central labs to ensure the PSAs are accurate and set-up according to the database expectations, including quality checks to compare vendor data against Labs Connect data
• In partnership with the CLA, manage the process of database lock preparation, including running Labs Connect reports to ensure data are complete, and identification of issues that need to be resolved to enable on-time database delivery
• Provide technical and logistical consultation regarding laboratory database creation, sample and data tracking, and database lock processes
• Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to CLS sample and data deliverables
• Perform all additional tasks given by the CLS Management.
• Process Application and Improvement
• Develop and implement training activities and materials related to department processes to ensure employees understand the processes related to the use of SMaRT tool, PSAs, and data lock processes
• Understand/recognize process issues and/or gaps and drive to resolution
• Participate in functional and cross-functional process improvement initiatives
• Work to improve existing processes and to implement new processes in an efficient manner
• Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirements
• Participate fully in Lilly’s performance management process

Minimum Qualification Requirements:

• 1-2 years professional experience
• Proficiency in working with data in spreadsheets (e.g. creating spreadsheets and tables, analyzing data, macros, pivot tables, formulas, etc.)
• Strong communications skills (both verbal and written) and strong business application skills (e.g., Microsoft Excel, Word, PowerPoint and SharePoint)

Other Information/Additional Preferences:

• Detail-oriented to ensure accurate work product on a consistent basis
• Strong self-management skills
• Strong time management and prioritization skills
• Demonstrates strong teamwork skills and ability to influence others
• Ability to work under tight timelines
• Understanding of clinical laboratory processes (including central lab operations)
• Knowledge of clinical drug development
• Experience with laboratory information systems
• Coding and programming experience

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$14.61 - $40.87
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

WeAreLill

• Communication/Information Management
• Manage investigator and study team requests for access to central laboratory vendors’ site portals (during the study start-up process as well as throughout the study) and provide reports to CLAs/teams regarding user access listings
• Maintain a tracker of initial kit shipments to investigator sites and other study start-up reports, as well as investigate questions or issues for ongoing study shipments
• Assist with study start-up processes such as obtaining necessary import of record (IoR) information from the study team and provide proforma invoices as needed
• Utilization of the SMaRT system related to sample tracking from the sites to the testing laboratories as well as the results delivery associated with those clinical trial samples. This includes ensuring the appropriate follow-up occurs when samples or data do not appear to be moving through the system.
• Utilize SMaRT to merge laboratory information from different systems and manual spreadsheets in order to track missing samples and their status
• Create and utilize dashboards to report our metrics to clinical teams and leadership
• Monitor for data errors and vendor transmission issues
• Assess study issues and impact on study timelines
• Prepare and submit laboratory panic/hepatic/toxicity alert emails to the study team and file them within the appropriate CLS location
• Upload study documents into the electronic trial master file (eTMF)
• Review and set-up Protocol Specific Addendum (PSA) for clinical trials (the Associate will approve the PSA), serving as the person who liaises with the CLA, CSSP and central labs to ensure the PSAs are accurate and set-up according to the database expectations, including quality checks to compare vendor data against Labs Connect data
• In partnership with the CLA, manage the process of database lock preparation, including running Labs Connect reports to ensure data are complete, and identification of issues that need to be resolved to enable on-time database delivery
• Provide technical and logistical consultation regarding laboratory database creation, sample and data tracking, and database lock processes
• Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to CLS sample and data deliverables
• Perform all additional tasks given by the CLS Management.
• Process Application and Improvement
• Develop and implement training activities and materials related to department processes to ensure employees understand the processes related to the use of SMaRT tool, PSAs, and data lock processes
• Understand/recognize process issues and/or gaps and drive to resolution
• Participate in functional and cross-functional process improvement initiatives
• Work to improve existing processes and to implement new processes in an efficient manner
• Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirements
• Participate fully in Lilly’s performance management proces