Specialist, HBS and IHD reuse (temp for 12 months)

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