Clinical Lab SME and LIMS Lead Consultant

LEAP Consulting Group specializes in providing modern and practical solutions for laboratory operations. We focus on genetics, multi-specialty, research, high-throughput clinical diagnostic laboratories in routine clinical, oncology, rare disorders, genetic screening, and multi-omics. Leap supports CLIA, CAP, and FDA-regulated laboratories. Our goal is to empower clinical and research laboratories by combining expertise in laboratory workflows and automation, our industry-specific buy vs. build insights, and our deep experience in system implementation so that labs can tackle today's challenges and prepare for tomorrow's opportunities.

We seek a Clinical Lab and LIMS Lead to drive Leap initiatives that assist laboratory leaders in selecting and implementing essential systems that enhance workflows, boost overall efficiency, oversee LIMS implementations, and manage lab automation projects. Examples include portals, LIS, LIMS, instrument interfacing and automation, revenue-cycle, and clinical workflows such as genetic counseling. This position is ideal for professionals with a strong foundation in laboratory workflows and hands-on expertise in implementing and optimizing laboratory systems, either as a technology team member or as a laboratory operations leader. The Clinical Lab and LIMS Lead will contribute to high-impact initiatives, including digital transformation projects, pre-analytical systems development, laboratory automation, bioinformatics, and revenue cycle optimization.

Reporting to the Healthcare Practice Lead, you will be a strategic partner to our clients, bridging the gap between laboratory operations and transformative technology. You will partner with clients and vendor partners to design and implement solutions that meet Leap clients’ needs. This role requires a unique blend of lab experience at the bench, leading lab operations, robust computer systems and software insight, and leadership capabilities to ensure successful project delivery and client satisfaction. You will engage in diverse projects, from conceptualizing laboratory workflows to managing LIMS architecture and beyond, fostering innovation and operational efficiency within the healthcare and life sciences sectors. You will be a pivotal contributor to Leap’s engagement model. You will be responsible for engagement management responsibilities, in addition to your client contributions, such as effort and timeline estimations, participating in pre-sales prospective client interactions, and account management discussions with existing clients on how to continuously improve engagements and expand the impact of Leap’s work at the client.

This position offers the opportunity to work collaboratively with a multidisciplinary team of experts while delivering a measurable impact in a dynamic and rapidly evolving industry. You will be supported by Leap practice leaders, principals, analysts, software architects, and lab systems engineers, who will help plan and execute the projects you lead. Leap will ensure you receive the proper training and certifications required to support Leap’s strategic vendor partnerships at no expense to you.

Key Responsibilities

Strategic Analysis & Project Leadership:

• Collaborate with clients to define project vision and strategy.
• Perform gap analyses and risk assessments to deliver actionable project or product roadmaps.
• Develop and maintain plans for client delivery utilizing Google Workplace tools, JIRA, Confluence, Draw.io, Gliffy, LucidChart, and other tools in a hybrid-Agile delivery model.
  
  

Workflow Analysis & Optimization:

• Design and refine detailed laboratory workflows, including all bench-level processes, from specimen handling to automation.
• Create easy-to-follow visual representations and specifications for use in automation, regulatory submissions, billing, and systems development.
• Ensure project deliverables are documented, updated, and communicated effectively.
  
  

LIMS Implementation:

• Translate laboratory needs into development tasks and oversee implementation on leading LIMS platforms.
• Guide platform selection and architecture for new LIMS solutions and workflow transformation for existing LIMS to make workflows more efficient and SOPs best suitable for validation and regulatory submission.
  
  

Cross-Functional Collaboration:

• Partner with laboratory leaders, IT teams, and automation experts to deliver integrated and scalable solutions.
• Mentor team members and ensure seamless transitions from requirements to execution.
  
  

The ideal candidate will have experience in laboratory wet workflows and computer science or engineering, with hands-on involvement in developing and implementing LIMS solutions. Alternatively, candidates with strong LIMS expertise and significant exposure to laboratory operations will also be considered, especially those with a medical technology (med-tech) background.

Target Qualifications:

• Bachelor’s degree in a related field (e.g., Computer Science, Medical Technology, or Laboratory Science).
• 5-7 years of experience in laboratory operations or as a Business Analyst/Functional Technical Analyst in a clinical or diagnostic laboratory.
• Hands-on expertise with commercial LIMS, from implementation to optimization.
• Strong understanding of laboratory wet workflows, automation systems, and bringing new assays online.
• Proficient in bridging technical and business needs with exceptional communication skills.
• Adept at conceptualizing and driving architecture for LIMS implementation, including data modeling, data flow, systems integration, UX design, and other relevant components.
• Experience working in a hybrid-Agile framework utilizing tools such as JIRA and Confluence.
• Knowledge of Agile methodologies and willingness to learn scripting languages like Python.
• Independent, resourceful, and team-oriented, with a proven ability to manage complexity.
  
  

Preferred Qualifications:

• Experience with laboratory automation, bioinformatics, or digital transformation.
• Familiarity with regulatory and compliance requirements for clinical labs.
• Experience with specific LIS and LIMS Sapio Sciences, SCC Soft, LabVantage, LabOS, LabWare, ClarityLIMS, and SLIMS.
• Experience with Agilent, Hamilton, Tecan, Qiagen, Beckman, ThermoFisher, Roche, and other lab automation platforms.
• Experience with any combination of high throughput FDA-approved, validated LDTs, and/or an RUO laboratory workflows in Hematology, FISH, FLOW, *ISH, Cyto, Molecular including NGS, and spatial assays within Multi-Omics across a wide variety of specimen types.
• Previous involvement in developing portals for patients, physicians, genetic counselors, etc.
• Involvement in pathologist, genetic counselor, and other report drafting and lab sign-out workflow.
• Experience supporting end-to-end commercial insurance billing workflows from either IT or lab operations.
  
  

Be comfortable communicating in-person, by phone, over video, as well as collaboration chat tools such as Slack

Be a self-starting independent team player who is both professional and kind to colleagues and customers

Be tech savvy and ideally consider yourself 'fairly technical'

All your information will be kept confidential according to EEO guidelines.

This hybrid role offers flexibility with remote work, the frequency of visits to the New Jersey office dependent on distance, and occasional travel to client sites.