Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 26 2022
Is there any greater challenge than getting ahead of disease? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. JOB DESCRIPTION:-

• One Development – Global Clinical Operations - Clinical Laboratory Sciences department conduct laboratory testing on human samples collected in vaccine epidemiology and clinical development studies to generate reliable data that will support GSK developments.

• 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.
  The CLS laboratory network is made from:
  • GSK Laboratories in charge of development, validation and/or routine of vaccine response assays
  • Central laboratories in charge of global laboratory support to clinical studies such as sampling material delivery, sample management, support to testing oversight (e.g. subject’s safety parameter evaluation).
  • Research laboratories in charge of development and/or validation of new vaccine response assays as well as inter-laboratory method transfer.

KEY RESPONSIBILITIES:-

• For a project or a group of studies, ensure effective interface between Clinical Laboratory Sciences and Clinical Study Team, especially the Study Delivery Lead, 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.
• Be the Clinical Study Team voice within Clinical Laboratory Sciences to communicate needs and constraints in terms of sample management & laboratory support.
• According the GSK POL-410 and related guidance, be the human bio specimen custodian for the study, from study start to study end.
• Provide input in development of study protocol and related documents and establish the operational feasibility of each new study protocol. Escalate detected feasibility issues at both Clinical Study Team and Clinical Read-Out Team levels.
• 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 bio specimen 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 CLS in line with the approach agreed with the clinical study team.
• Manage the bio specimen pick-up from clinical site to a central lab or a blood cells preparation lab.
• Follow-up central lab management of bio specimen and related data, support testing oversight when conducted in central labs (e.g. safety testing).
• Ensure study milestones are respected by CLS functions.
• Follow up on study KPIs, identify trends and ensure problems are addressed.
• Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of LSMs, e.g. bio specimen custodian, study set-up with central laboratory, BFL process, blinding & reconciliation strategy, etc.
• Direct and main responsible to deliver Laboratory Study Manager services for a study or a group of studies by working in a dotted line with a team of FSP resources.
• First point of escalation for the clinical study teams where the laboratory study manager at the FSP is the first point of contact at a study level. Understand, mediate and solve complex issues related to LSM deliverables and escalate as required.
• Monitor project 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.
• Ensure alignment in the ways of working for a project or a group of studies by example reviewing the set-up at central laboratory level.

OTHER INFORMATION:- Education

• Master’s degree in sciences or equivalent background

Knowledge

• Demonstrated expertise in Project Management beyond his/her own field of expertise
• Demonstrated capability to integrate complex inter-departmental links, processes, databases and systems
• Demonstrated generalist knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules
• Demonstrated fluency in spoken and written English beyond scientific English, knowledge of French is an asset
• Good helicopter view especially to proactively detect problems and define possible solution and/or to surface issues to Management

Experience

• 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
• Experience of GSK Vaccines clinical development processes and ability to quickly integrate Global Vaccine Laboratories network to build strong partnership with his/her customers
• Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background
• Ability to align of 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
• FDA or other competent authority inspection exposure
• Experience of budget management
• Experience in direct & indirect people management is an asset

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

• LI-GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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