Position Summary
You will be an expert and manage HBS (Human Biological Sample) Reuse Check activity, ensuring that the patient’s consent and associated documentation is in line with the research use of HBS and IHD.
Responsibilities
Responsible for the HBS and IHD Reuse Check activity (Informed Consent Form: permission obtained from a patient to perform a specific test or procedure), which includes
Perform ICF check: ensure that the use of Human Biological Sample (HBS) is in line with the patient consent, the POL_87187 (Human Subject Research) and the SOP_285822 (Management of Human Biological Samples in Research):
Consult the local ICF/ IC SCTF available on e-TMF
Analyse the wording of the local ICF regarding the purpose of the request
Give a positive or negative answer to the requester
Carry out the ICF assessment of the external HBS providers and participate in the “Acquisition Team” meeting
Conduct the ICF assessment within the scope of a project’s divestment
Keep the procedures linked to the activity up to date
Attend and prepare the DSAP (Data and Approval Panel Meeting). The objective of this meeting is to address and discuss the request for which a decision cannot be endorsed neither by the HBS and IHD Reuse Check Team nor by the responsible of the activity
Participate in the annual report to the ERASME Ethical Committee in the framework of the GSK Vaccines Biobank
Improve and optimize processes.
Handle issues linked to these processes in accordance with regulations, etc.
Identify and implement projects' improvements without impairing client's services and quality/compliance
Identify risks linked to process
Monitor the activity, manage the backlog and escalate issues on due time
Guarantee GCLP, EHS, legal and ethical compliance when using Human Biological Samples
Maintain good cooperation with the teams involved (Stock Management, Lab Study Managers, Data Management, GCO, HBSM Risk Coordinator, Vx CMOs Office Management Oversight, Biobank Manager, etc.)
Be a contact key for customers (HBS user from R&D centres) regarding the HBS and IHD Reuse Check process
Be a reference for the HBS and IHD Reuse Check Team
Why You?
Master’s degree in sciences or equivalent acquired background through experience
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
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 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
Experience in leading various operational meetings
FDA or other competent authority inspection and audit exposure
#Li-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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