New

Project Manager

Spectraforce Technologies
United States, Illinois, North Chicago
Nov 25, 2025
Position Title: Project Manager - Clinical Sample Operations Work Location: Waukegan Road, North Chicago, IL 60064 Assignment Duration: 1 year from start date Work Schedule: 1st shift, 8 hours M F Work Arrangement: Beginning 100 percent onsite and can move to hybrid schedule. Onsite on TU, W, TH, can be remote on M, F Position Summary: Laboratory Systems Operations (LSO) group is a key study team partner in the lab engagement process and plays a critical role in supporting The Organization Clinical Trials. For every clinical study, LSO assists with the development, review and approval of study specific documents based on study protocol. Background and Context: One of key documents LSO manages is a lab specification document which is a critical study start up document and provides sample collection, treatment, storage and shipment logistics for all patient sample types. Role supports studies across Phase I-IV depending on assignments and LSOPM availability. Candidate will collaborate with internal and external teams, including central labs, regulated bioanalysis, biomarker teams, PMED, and vendors. Qualification and Experience: Bachelor's degree in life sciences or equivalent field of study is required. Knowledgeable in clinical trials, the end-to-end GLP, clinical study and sample lifecycle. 1 to 3 years of clinical study involvement and/or sample processing experience in a GLP regulated environment preferred. 5 plus years of preferred. Experience with clinical sample lifecycle, including collection, storage, shipment, and logistics, is highly valuable. Laboratory automation experience is a plus but not required. Proficiency in Microsoft Excel and Word required. Key Responsibilities: Oversee the production of Laboratory Systems Operations (LSO) deliverables for assigned clinical trials. Oversee all LSO timelines for assigned clinical trials and cross functional meetings for assigned clinical trials. Coordinate discrepancy resolution efforts needed for complex issues that arise with the sample receiving team. Represent LSO team in vendor meetings to ensure timely response to projects and or identified issues. Act as primary liaison with Regulated Bioanalysis, Biomarker Groups and Central Labs to ensure that priority project deliverables are met. Plans and manages LSO timelines for assigned clinical trials, specifically the completion of the Lab Specifications and Kit Delivery. Participates in vendor meetings to ensure proper representation for LSO and timely resolution of outstanding issues. Manages all process flows and data exchanges with any vendors or internal data providers or consumers. Assists with the development and review of trial specific SOW, Laboratory manuals, Data mapping documents based on parameters supplied with MSA with applicable vendors and clinical protocol. Participates in cross functional meetings where LSO tasks are discussed. Continually seeks to improve existing processes. Develops productive collaborations and communication with other cross functional groups. Ensures compliance with current SOPs. Participates in any internal quality assurance audits. Manages sample storage volumes and the sample lifecycle management process.