Project Manager

Description

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 Clinical Trials. For every Cient 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.

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. 

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills 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.
• 1-3 years of clinical study involvement and/or sample processing experience in a GLP regulated environment preferred
• Laboratory automation experience is a plus.

What are the top 3-5 skills, experience or education required for this position:

• 5+ years of sample processing experience in a GLP regulated environment preferred
• Bachelor’s degree in life sciences or equivalent field of study is required.
• Knowledgeable in clinical trials, end-to-end GLP, clinical study and sample lifecycle.