Nom du site: Canada - Ontario - Mississauga
Data de publication: Nov 29 2024
One Development – Human Biological Samples Management Central Team (HBSMCT) support Medicines Clinical trials involving Human Biological Samples (HBS) that are collected, stored, transferred, analysed, and destroyed as part of the clinical trial. The management of the HBS and associated laboratory activities need to be coordinated in a manner that ensures compliance (ethical, legal, and regulatory) and quality to appropriate standards.
The Laboratory Study Manager within HBSM-CT is responsible for the operational setup & follow-up of central 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 laboratory results timely at right quality and cost. The laboratory network is made from:
- Central laboratories (CL) in charge of global laboratory support to clinical studies such as sampling material delivery, sample management, support to testing oversight.
- GSK Laboratories in charge of development, validation, and sample analysis. o Third Party Laboratories in charge of development, validation, and sample analysis
- Vendors/Laboratories responsible for long-term storage of untested HBS (for future research).
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Key responsibilities
For a project or a group of studies, lead activities related to HBSM and ensure effective interface between Clinical laboratories and GSK Clinical Study Team including members such as: Study Delivery Lead (SDL),CPEM, Oncology-EMU IVIVT, Human Genetics. Provide input in clinical study protocol development (clinical laboratory part) including laboratories set up and instructions for investigators sites. Be main point of contact for the clinical study team regarding clinical laboratories, a well as responsible for overview of HBSM in the assigned projects including support for investigator sites (mainly based on the cooperation with the Local Delivery Leads – LDLs) and testing issues in CL Be the HBS custodian for the study, from study start to study end according to the GSK HBSM SOP and related written standards. For each study, define the operational set-up to align HBS flows, testing activities and data flows (in cooperation with GSK Data Management) and assure it is in line with the other stakeholder’s constraints. Own the BFL (Biospecimen Flow & Logistics Form) and Samples Risk Assessment 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 site - central lab and provide consultations for HBSM CT in case of HBSM by Third Party Laboratories. Act as Central Laboratory Subject Matter Expert (SME) 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., HBS custodian, study set-up with central laboratory, BFL process, blinding & reconciliation strategy, etc.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals,
- Master’s degree in medical/life sciences or equivalent background.
- Demonstrated expertise in Project Management beyond their own field of expertise.
- Demonstrated capability to integrate complex inter-departmental links, processes, databases, and systems.
- Demonstrated knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules.
- +5 years operational experience in clinical laboratory activities and clinical study conduct
- +3 years proven experience in clinical project planning, project management and issues resolution
Preferred Qualifications:
If you have the following characteristics, it would be a plus,
- Ability to quickly integrate with GSK clinical development processes and global network to build strong partnership with lab vendors and GSK stakeholders.
- 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 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 and FDA or other competent authority inspection exposure
- Experience of budget management
- Experience in direct & indirect people management is an asset.
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