Senior Specialist, Clinical Lab Study Management
il y a 1 mois
**Site Name**: Belgium-Rixensart
**Posted Date**: Dec 12 2024
**_
Job purpose:_**
The Laboratory Study Manager within HBSM Central Team is responsible for the operational set-up & follow-up of laboratory related activities for a project or a group of studies to guarantee alignment amongst the entire network and with Clinical Operations to support delivery of clinical results timely and at the right quality and cost.
The 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.
**_
Your responsibilities:_**
This role will provide YOU the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
- For a project or a group of studies, ensure effective interface between the HBSM Central Team 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 HBSM Central Team point of contact for the clinical study team.
- Be the Clinical Study Team voice within HBSM Central Team to communicate needs and constraints in terms of sample management & laboratory support and escalate to CRT-L at asset level (on the study portfolio level).
- According to procedure and related guidance, be the Human Biological Samples (HBS) custodian during the clinical study.
- Provide input in development of study protocol and related documents and establish the operational feasibility of each new study protocol. Escalate potential feasibility issues at both Clinical Study Team and Vaccines Clinical Laboratory & Assay Portfolio Team.
- Report newly planned studies and new demand in ongoing studies through HBSM Central Team capacity management processes.
- For each study, define the operational set-up to align biospecimen flows, testing activities and data flows and assure it is in line with the other stakeholder’s constraints. Own the BFL (Biospecimen Flow & Logistics Form) 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.
- Manage the biospecimen pick-up from clinical site to GSK Laboratories, a central lab, third-party labs and/or a blood cells preparation lab.
- Follow-up central lab management of biospecimen and related data, support testing oversight when conducted in central labs (e.g., safety testing).
- Ensure study milestones are respected by HBSM Central Team & Vaccines Clinical Laboratory & Assay Portfolio Team.
- 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., biospecimen custodian, study set-up with central laboratory, BFL process, blinding & reconciliation strategy, etc.
- 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.
- Able to evolve in a changing and challenging environment, coaches the study team members to focus on value, building business agility and embracing change.
- Excellent networking capabilities and ability to influence and manage stakeholders at all levels of the organization. The ability to facilitate and lead cross functional meetings/challenge status quo and inefficient ways of working and need to be comfortable in a mediation role.
**_
Why you?_**
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Master’s degree in sciences or equivalent background
- At least 5 years of operational experience in clinical study conduct, preferably in clinical laboratory activities.
- Proven experience in clinical project planning, project management and issues resolution
- Demonstrated expertise in Project Management beyond his/her own field of expertise.
- FDA or other competent authority inspection exposure
- Experience of budget management
- Experience in direct & indirect people management is an asset.
- 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 especiall
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