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Duration: 12+ months contract

Job Description:

+ **Laboratory Systems Operations (LSO)** group is a key study team partner in the lab engagement process and plays a critical role in supporting client’s Clinical Trials. For every **client’s clinical study, LSO assists with the development, review and approval of study specific documents based on study protocol** . 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.**

Responsibilities:

LSO responsibilities include but not limited to:

+ 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.

Major Responsibilities:

List up to 10 main responsibilities for the job. Include information about accountability and scope.

+ 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/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.

Experience:

**Required Qualifications** :

+ Knowledgeable in **clinical trials the end-to-end GLP, clinical study and sample lifecycle** .

+ **1-3 years of clinical study involvement and/or sample processing experience in a GLP regulated environment preferred**

+ Laboratory automation experience is a plus.

Skills:

+ **Clinical Trial, Clinical Study, Sample management, Logistics, storage, GLP, Lab automation**

Education:

+ Bachelor’s degree in life sciences or equivalent field of study is required.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.