Nicholas Simpson
Indianapolis,IN
Summary
Dynamic and results-driven clinical laboratory sciences manager with over nine years of experience in leading and managing complex global studies across multiple therapeutic areas, including EMP, oncology, diabetes, and obesity. Demonstrated expertise in global trial oversight, study design, end to end execution, risk mitigation, and problems solving. Skilled in project management, cross-functional team leadership, and vendor management, with a proven ability to resolve complex technical and operational issues independently. Adept at influencing study design, driving process improvements, and ensuring compliance with regulatory standards. Recognized for fostering innovation, continuous improvement, and maintaining inspection readiness. Committed to delivering high-quality clinical programs and advancing clinical research methodologies.
Overview
9
9
years of professional experience
Work History
Manager - Clinical Laboratory Sciences
Eli Lilly
03.2023 - Current
- Leads, influences, and efficiently manages multiple large complex global studies across several therapeutic areas including both early (EMP) and late phase (Oncology, Diabetes & Obesity) trials
- Provides expertise and consultation relating to clinical laboratory, ECG& Connected device, imaging, sample storage, and other diagnostic biomarkers including assay development and validation
- Drives, demonstrates credibility, and influences internal cross functional teams as well as business partners to make timely decisions throughout the study
- Anticipates and resolve complex key technical, operational, and business problems with cross functional team (including vendors, affiliates, regional/global team members, and other business partners) with little to no need for direct management support
- Leverages scientific knowledge, trial process, and therapeutic/disease testing expertise to influence study design during protocol authoring process to ensure laboratory and device feasibility to enabling end to end delivery of clinical programs
- Responsible for resolving and/or escalating issues to ensure timely resolution and future risk mitigation
- Monitors study status, benchmarks, and adjusted project needs (per change control process) as needed to meet ongoing requirements for trial deliverables
- Works with internal team to track global trial plan by gaining alignment and integrating inputs across functions and geographies
- Provide peer coaching within the organization that fosters inclusion and innovation, continual improvement, and an external awareness and understanding
- Participating in STA within CLS Connected Device group focusing on vendor management strategy, oversight, metrics reviews, and governance across multiple vendors
- Participating and co-leading audit initiative to address overall audit findings, drive process improvements, and provide focus driven solutions toward future process state
- Created multiple project management and timeline tools to support continuous improvement of quality, productivity and consistency of trial delivery.
Senior Associate - Clinical Laboratory Sciences
Eli Lilly
03.2021 - 03.2023
- Provide technical and logistical consultation regarding clinical laboratory, ECG & Connected device, imaging, sample storage, and other diagnostic biomarker issues and services support as needed for assigned trial(s)
- Provide input and review of the protocol related to clinical laboratory, device, and diagnostic needs
- Provide and oversee clinical testing plans and study risk oversight as it pertains to clinical labs, diagnostic data reviews, and lab managements plans
- Utilize strong working knowledge of Regulatory bodies, Ethical Review Boards, Good Clinical/Laboratory Practices (GC(L)P), and International Committee on Harmonization (ICH) guidelines Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment
- Proactively identify and monitor issues/trends and escalate issues as warranted to upper management
- Drive communications to prospectively manage upcoming cross-functional activities, key milestones, and decisions as well as to proactively identify updates to schedule and partner with clinical to optimize timeline
- Articulate the value of clinical laboratory solutions in terms of reliability, time, cost, quality and scalability
- Monitor trial budgets and ensure FRAP compliance
- Maintain accurate budget information and defined protocol testing in the Laboratory and Diagnostic tool
- Maintain inspection readiness at all times by maintaining a complete eTMF at a trial level.
Global Project Manager
Cerba Research
05.2020 - 11.2020
- Acts as a consultant to all levels within the client organization advising on best practices, study design choices and study delivery timelines
- Fosters relationships with clients to influence and effectively manage project/study expectations
- Accountable for global/regional enrollment strategy and execution from trial design through study closure
- Actively participates in contracting processes, aiding in effective forecasting and feasibility discussion around operational study cost
- Effectively demonstrates project management, problem solving, negotiation, and issue resolution skills with clients as it pertains to study design and execution
- Creates integrated risk mitigation plans to identify areas of process breakdown and propose innovative approaches that positively impact projects
- Applies expertise and knowledge of International Committee on Harmonization (ICH), Good Clinical Practices (GCP), and operation standard to comply with global/regional regulations for the conduct of clinical trials
- Liaises with cross-functional departments to increase communication and understanding of capabilities, accountability, and deliverables to meet client study needs and manage client relationships
- Works with internal operations teams to identify opportunities to support continuous improvement of processes and procedures.
Sr. Study Design Lead
Labcorp Central Laboratory
05.2015 - 04.2020
- Leveraged and demonstrated project management, therapeutic area, molecule/indication and process knowledge to influence the study design, development, and execution
- Worked with client functional teams to provide comprehensive and complete Statement of Work (SOW) based on design requirement, sponsor protocols and testing requirements
- Acted as a consultant for assay methodology, Biomarker/Specialty testing and service offerings during new study development
- Frequently assisted with bid proposals and sales process to ensuring feasibility of service offerings
- Networked and leveraged expertise to anticipate issues, identify areas of process breakdown, analyze situations, and propose innovative approaches that positively impacted the ability to deliver the services
- Performed on-site SOW design, feasibility, and budgetary risk assessment training for sponsor-vendor engagement and learning forums
- Worked with client and internal operations teams to identify new tools, processes, or methodologies to support continuous improvement of quality, productivity and consistency of global partnership processes and procedures
- Acted as mentor and team functional lead to educate and train new study team members and peers on internal services and processes, study design and best practices and procedures.
Education
Bachelor of Science - Biology with Honors -
Purdue University
West Lafayette, IN05.2010
Skills
- Project/Operations Management
- Vendor Relationship Management
- Cross-Functional Teamwork
- Team Leadership
- Time Management
- Risk Mitigation
- Complex Problem-Solving
- Strategy development
- Effective verbal and written communication
- Staff Training and Development
Accomplishments
2-time Lilly Innovator Award Recipient
Timeline
Manager - Clinical Laboratory Sciences
Eli Lilly
03.2023 - Current
Senior Associate - Clinical Laboratory Sciences
Eli Lilly
03.2021 - 03.2023
Global Project Manager
Cerba Research
05.2020 - 11.2020
Sr. Study Design Lead
Labcorp Central Laboratory
05.2015 - 04.2020
Bachelor of Science - Biology with Honors -
Purdue University
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