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    Sr. Specialist/Expert Specialist - Clinical Laboratory Services

    Eli Lily
    1-2 years
    Not Disclosed
    Cork
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Sr. Specialist/Expert Specialist - Clinical Laboratory Services
    Location: Cork, Cork, Ireland
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-79477

    Company Overview:
    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, we are committed to discovering and delivering life-changing medicines, improving the understanding and management of diseases, and giving back to our communities. We aim to create an environment where people work together with passion to improve lives, and we're looking for individuals determined to make a positive impact.

    Position Overview:
    We are seeking a highly motivated Sr. Specialist/Expert Specialist - Clinical Laboratory Services to play a key role in the management and tracking of clinical trial laboratory samples and data. This position will support the creation and maintenance of clinical trial laboratory databases, ensure timely receipt of laboratory data, and assist in preparing study database locks. The ideal candidate will have a solid understanding of clinical laboratory processes, sample tracking, and data management.

    Key Responsibilities:

    Communication & Information Management:

    • Manage investigator and study team requests for access to central laboratory vendor portals, providing access reports during study start-up and throughout the study.
    • Maintain a tracker of initial kit shipments to investigator sites and other study start-up reports.
    • Assist with study start-up processes, including obtaining necessary import of record (IoR) information from the study team and providing proforma invoices.
    • Utilize the SMaRT system to track clinical trial samples from collection to testing and ensure data is delivered as expected. Follow up on samples or data that are not moving through the system.
    • Merge laboratory information from different systems and spreadsheets to track missing samples and their status.
    • Create dashboards to report metrics to clinical teams and leadership.
    • Monitor and resolve data errors and vendor transmission issues.
    • Serve as the query escalation point for CLS, ensuring site queries are resolved and closed.
    • Prepare and submit laboratory panic/hepatic/toxicity alert emails to the study team and file them appropriately.
    • Upload study documents into the electronic trial master file (eTMF).
    • Review and set up Protocol Specific Addendum (PSA) for clinical trials, ensuring they are accurate and aligned with database expectations.
    • In partnership with the CLA, manage database lock preparation, including generating Labs Connect reports and resolving issues to ensure timely database delivery.
    • Provide technical and logistical consultation on laboratory database creation, sample and data tracking, and database lock processes.
    • Maintain communication with management, customers, and vendors to address issues and improve trial-level processes.

    Process Application & Improvement:

    • Develop and implement training activities and materials for department processes related to the use of the SMaRT tool, PSAs, and data lock processes.
    • Identify and drive resolution of process issues or gaps.
    • Participate in functional and cross-functional process improvement initiatives.
    • Contribute to the implementation of new processes and improvements in efficiency.

    Self-Improvement:

    • Ensure compliance with departmental, Medical Quality System (MQS), and Lilly Research Laboratory (LRL) training requirements.
    • Participate in the performance management process and engage in continuous self-improvement.

    Basic Qualifications:

    • Bachelor's Degree in Medical, Science, or a related field.
    • 1-2 years of professional experience.
    • Proficiency with data analysis in spreadsheets (e.g., creating tables, analyzing data, using macros, pivot tables, formulas, etc.).
    • Strong communication skills (both verbal and written) and proficiency in Microsoft Office tools (Excel, Word, PowerPoint, SharePoint).

    Additional Skills/Preferences:

    • Detail-oriented and able to maintain accuracy in all tasks.
    • Strong self-management, time management, and prioritization skills.
    • Demonstrates strong teamwork skills and the ability to influence others.
    • Ability to work under tight timelines and pressure.
    • Understanding of clinical laboratory processes, including central lab operations.
    • Knowledge of clinical drug development.
    • Experience with laboratory information systems.
    • Coding and programming experience is a plus.

    Equal Opportunity Employer:
    Lilly is committed to providing equal opportunities for all individuals, including those with disabilities. If you require accommodations during the application process, please submit an accommodation request form. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or any other legally protected status.

    #WeAreLilly

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