Senior Specialist, Clinical Lab Study Management - Rixensart, België - GSK

GSK

Geverifieerd bedrijf

Rixensart, België

2 weken geleden

Geplaatst door:

Sophie Dubois

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Beschrijving

Site Name:
Belgium-Rixensart

Posted Date:
Jun

_ About the role_:

One Development - Global Clinical Operations

Clinical Laboratory Sciences (CLS) department conduct laboratory testing on human samples collected in vaccine epidemiology and clinical development studies to generate reliable data that will support GSK developments.

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.

The CLS laboratory network is made from:

_GSK Laboratories_ in charge of development, validation and/or routine of vaccine response assays

- _Research laboratories_ in charge of development and/or validation of new vaccine response assays as well as inter-laboratory method transfer.

_ About the responsibilities_:

For a project or a group of studies, ensure effective interface between Clinical Laboratory Sciences (CLS) 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 POL410 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 setup 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 setup and conducted in CLS in line with the approach agreed with the clinical study team.
Manage the bio specimen pickup from clinical site to a central lab or a blood cells preparation lab.
Followup 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 setup 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 setup at central laboratory level.

_ About you_:

Master's degree in sciences or equivalent background
Demonstrated expertise in Project Management beyond his/her own field of expertise
Demonstrated capability to integrate complex interdepartmental links, processes, databases and systems
Demonstrated generalist knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules
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
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
High level of stress management and resilience
Sense of prioritization and assertiveness
Good communicator and real team player

LI-GSK

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