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Job Details


GlaxoSmithKline (GSK)

Laboratory Study Manager ( Vx)

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a we empower you to be yourself, share ideas and work collaboratively

The Laboratory Study Manager within CLS Clinical Sample Strategy & Management Group is responsible for the operational set-up & follow-up of laboratory related activities for a project or a group of studies to guarantee alignment among the entire network and with Clinical Operations to support delivery of clinical results timely at right quality and cost.

Some of the responsibilities will include:

  • For a project or a group of studies, ensure effective interface between Clinical Laboratory Sciences and Clinical Study Team, by providing input in study protocol, laboratory instructions for investigator sites, informing about testing due dates, sample management or testing issues.
  • Be the CLS point of contact for the clinical study team.
  • Provide input in development of study protocol and related documents and establish the operational feasibility of each new study protocol. Escalate detected feasibility issues to the Clinical Study Team.
  • Report newly planned studies and new demand in ongoing studies through CLS capacity management processes.
  • For each study, define the operational set-up to align HBS flows, testing activities and data flows and assure it is in line with the other stakeholder’s constraints. Own the BFL (Bio specimen Flow) process and documents. Ensure that all study related activities are operationally set-up and conducted in line with the approach agreed with the clinical study team.
  • Oversight of chain of custody of HBS throughout the lifecycle of the study, including central lab and associated 3rd Party laboratories.
  • Follow up on study KPIs, identify trends and ensure problems are addressed.
  • First point of escalation for the clinical study teams. Understand, mediate and solve complex issues related to LSM deliverables and escalate as required.
  • Monitor study related activities to provide management with consolidated information on central laboratory, sample management, data delivery, budget review & annual forecast as well as key performance indicators to surface issues.

Why you?

Basic Qualifications:
  • Min. Bachelor’s degree in sciences or equivalent background
  • At least 5 years of operational experience in clinical laboratory activities and clinical study conduct
  • Proven experience in clinical project planning, project management and issues resolution
  • Very good English and local language.
  • Project management experience

Preferred Qualifications:

  • Ability to align all the parties involved to build alliances and influence across national and cultural boundaries (up to 20 in different countries, including Africa and China)
  • Experience in leading various operational meetings
  • Experience of budget management
  • Experience in direct & indirect people management is an asset
  • Capability to integrate complex inter-departmental links, processes, databases and systems

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

We also offer:

  • Remote work (during pandemic)
  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)
  • Established job in an international, well-known pharmaceutical company
  • Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
  • Opportunity to work within GSK standards and documentation applied globally
  • Flexible working hours

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