Jobs

Description

Role is onsite

Recent grad PhD with central lab exp (5-10 yrs of relevant exp) will be considered

Masters degree will also work

5-10 yrs exp will be considered

• Key team partner in engaging clinical teams and study start up process for all clinical teams
• Lab system operations group assist with a lot of review of diff documents (one of the key document that the team is developing is the lab specification document)
• Lab specification document is used in conjunction to protocol to develop statement of work by vendors

Description

• Creating lab specification document
• Job responsibility will be creating lab specification document
• Engaging with different teams in company to gathering required information and confirming the required information
• Oversee timelines for development of lab specification document and coordinate with vendors and external vendors
• Review all documents that are part of startup process (SOW, lab manuals, requisition forms)
• Will participate in a lot of cross functional meetings and external partners and vendors
• Coordinate in any discrepancy resolution
• Manage samples forms start up process till disposal
• Engaging in setting up the contract or long-term storage and any discrepancy during the life cycle of sample
• Managing all the process flow and any data exchange with vendor and continuously try to improve the process and make improvement in existing process
• Ensure compliance with current SOP
• May be asked to participate in internal audits and be part of a bigger team
• BS degree in life science or equivalent
• Knowledge of clinical trials from start to finish
• Clinical study exp (1 - 3 yrs)
• Any exp in lab automation is a plus
• This position is not handling clinical samples but more of clinical studies set up: Tissue samples, blood samples, plasma samples, serum samples, storage samples for PK and biomarker)
• They will be working with teams and setting up the study and will not be doing sample processing
• This person will not do sample processing but will work on entire set up (Sample overseeing)
• Sample management or processing exp needed
• Someone who has worked with Central labs
• Able to us MS word, excel document needed
• This person draft documents from scratch using protocol and collaborating with other teams
• Document is study specific
• Use template that client has for document creation
• Work on Clinical Trials phase 1 to phase 4 (Every thing related to clinical trials)
• Sample processing is a plus
• Able to support cross functional teams
• Exp in central lab working with vendor is a plus
• Clinical Lab operations background needed
• Clinical trials operations background will also work
• Clinical research associate with site monitoring exp will work if they have central lab experience

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.