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.
At Eli Lilly Cork, 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 45,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse
People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Organization Overview:
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.

Responsibilities:

• 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
• Serve as the query escalation point for CLS by communicating with CRAs responsible for the site to ensure queries are resolved and closed
• 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
• Self-Improvement
• Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirements
• Participate fully in performance management process

Basic Requirements:

• Bachelors Degree in Medical, Science or related field
• 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)

Additional Skills/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 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.

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
• Serve as the query escalation point for CLS by communicating with CRAs responsible for the site to ensure queries are resolved and closed
• 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
• Self-Improvement
• Maintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirements
• Participate fully in performance management proces