Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Nov 3 2023
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\xe2\x80\x99s 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 to 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\xe2\x80\x99s 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.

Education

Master\xe2\x80\x99s 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 Why Us? GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in \xe2\x80\x9cgsk.com\xe2\x80\x9d, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.