Specialist, HBS and IHD reuse

GSK; Rixensart; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A global biopharma company is seeking an expert to manage Human Biological Sample (HBS) Reuse Check activities in Rixensart, Belgium. The role requires a Master's degree and at least 5 years of experience in clinical laboratory activities. Responsibilities include ensuring patient consent compliance, conducting assessments, and improving processes. The ideal candidate will have strong project management skills and fluency in English, with knowledge of French being an asset. This position offers a chance to make a meaningful impact in biopharmaceutical research.

Qualifications

• Minimum of 5 years of operational experience in clinical laboratory activities.
• Demonstrated expertise in project management beyond own field.
• Proven experience in clinical project planning and issues resolution.

Responsabilités

• Manage HBS and IHD Reuse Check activity ensuring patient consent compliance.
• Conduct ICF assessment of external HBS providers and manage escalated issues.
• Participate in product improvements to enhance processes and compliance.

Connaissances

Project Management

Collaborative skills

Problem detection and solution definition

Fluency in spoken and written English

Knowledge of French

Formation

Master’s degree in sciences or equivalent

Description du poste

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 escalated 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 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.

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.