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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 48.00/hr.