Associate Manager (PBMC) - 12 month FTC (R1114029) in Livingston, UK at IQVIA™

Date Posted: 1/21/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/21/2020
  • Job ID:
    R1114029

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

And-to-end delivery of analytical and pre-analytical lab services to support clinical trials. Includes kit receipt, specimen management, specimen preparation and lab analysis across a broad spectrum of methods and technologies.

Responsible for laboratory testing in accordance with applicable regulations governing clinical laboratories. Performs a wide variety of testing to product accurate, reliable and reproducible data to support clinical trials research; and ensures accurate and timely reporting of results.

Act as a technical specialist for laboratory operations including identifying and driving continuous process improvement initiatives and oversee the technology transfer process. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.

• Complete and prepare documentation in compliance with regulatory and corporate guidelines.

•Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.  Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.

• Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.

 • Act as a back-up in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.

•Oversee the technology transfer of methods and SOPs from other groups within Quintiles such as Research and Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.

• Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects. Including application of root cause analysis and advanced problem-solving techniques.

 • Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).

•Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:   

◦ Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.   

◦ Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.   

◦ Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.

Documentation of all project aspects including formal validations of laboratory methods.   

◦ Present findings to a wide variety of audiences internal and external to Quintiles.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience Typically requires a minimum of 2 years of prior relevant experience. Knowledge Ensures policies, practices and procedures are understood and followed by direct reports, customers and stakeholders

External Job Description

End-to-end delivery of analytical and pre-analytical lab services to support clinical trials. Includes kit receipt, specimen management, specimen preparation and lab analysis across a broad spectrum of methods and technologies. Sub-Family  Description

Responsible for laboratory testing in accordance with applicable regulations governing clinical laboratories. Performs a wide variety of testing to product accurate, reliable and reproducible data to support clinical trials research; and ensures accurate and timely reporting of results.

Act as a technical specialist for laboratory operations including identifying and driving continuous process improvement initiatives and oversee the technology transfer process. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines. • Complete and prepare documentation in compliance with regulatory and corporate guidelines.

•Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.  Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.

• Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.

 • Act as a back up in any area of daily laboratory operations, as needed,  and meet expectations of the  laboratory associate job responsibilities in that area.

•Oversee the technology transfer of methods and SOPs from other groups within Quintiles such as Research and Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.

• Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects. Including application of root cause analysis and advanced problem solving techniques.

 • Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).

•Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:  Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.   

◦ Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.   

◦ Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.

Documentation of all project aspects including formal validations of laboratory methods.   

 ◦ Present findings to a wide variety of audiences internal and external to Quintiles.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience Typically requires a minimum of 2 years of prior relevant experience. Knowledge Ensures policies, practices and procedures are understood and followed by direct reports, customers and stakeholders

PBMC experience is essential along with DNA extraction and/or molecular experience (Not essential)



Job ID: R1114029