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 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 patients around the world. 

Eli Lilly Cork, is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

The purpose of the CLS Specialist / Sr. 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 / Sr. Specialist will partner with CLS Associates, CLS Consultants, CSSP (CLRM 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 ManagementManage 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 listingsMaintain 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 shipmentsAssist with study start-up processes such as obtaining necessary import of record (IoR) information from the study team and provide proforma invoices as neededCompile study-specific vendor information for the creation of the 1572 form and/or other study documentsUtilization 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 statusCreate and utilize dashboards to report our metrics to clinical teams and leadershipMonitor for data errors and vendor transmission issuesAssess study issues and impact on study timelinesServe as the query escalation point for CLS by communicating with CRAs responsible for the site to ensure queries are resolved and closedPrepare and submit laboratory panic/hepatic/toxicity alert emails to the study team and file them within the appropriate CLS locationUpload 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 on CLRM buildQuality checks to compare vendor data against CLRM dataIn partnership with the CLA, manage the process of database lock preparation, including running CLRM reports to ensure data are complete, and identification of issues that need to be resolved to enable on-time database deliveryProvide technical and logistical consultation regarding laboratory database creation, sample and data tracking, and database lock processesMaintain open lines of communication with management, customers, and vendors to relay critical issues and improve trial level processes related to CLS sample and data deliverablesPerform all additional tasks given by the CLS Management.

Process Application and ImprovementDevelop 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 processesUnderstand/recognize process issues and/or gaps and drive to resolutionParticipate in functional and cross-functional process improvement initiativesWork to improve existing processes and to implement new processes in an efficient manner

Self-ImprovementMaintain compliance with all departmental, Medical Quality System (MQS) and Lilly Research Laboratory (LRL) training requirementsParticipate fully in performance management process

Basic Requirements:

Bachelor’s Degree or equivalent2+ years relevant work experienceProficiency 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 basisStrong self-management skillsStrong time management and prioritization skillsDemonstrates strong teamwork skills and ability to influence othersAbility to work under tight timelinesUnderstanding of clinical laboratory processes (including central lab operations)Knowledge of clinical drug developmentExperience with laboratory information systemsCoding 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.

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