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Investigator, PMed Scientific Operations (6-month FTC)

Would you like to be part of the Scientific Operations (SO) Group within the PMed group to provide operational management of Biomarker and Companion Diagnostic activities in Clinical Trial Assay Development; Clinical Trial Setup, Execution and Closeout; external Vendor Management; and Collaborations?

Key Responsibilities:

The Scientific Operations investigator is responsible for working with Associate Director/s, PMed Scientific Operations and Clinical Biomarker/Virology leads to deliver the biomarker/virology strategies through robust budget plans and optimal outsourcing engagements. This includes leading human biological sample management (HBSM) activities for biomarker samples within clinical trials for one or more GSK Asset Programs and spanning the GSK therapy area portfolio. In this role you will work closely with a wide variety of functions within GSK and external, to deliver the re

quired operational activities.  You will be accountable for ensuring all required details of the biomarker strategy are adequately described in the clinical protocol and informed consent.

Responsibilities,

• Implement operational delivery of biomarker strategies developed by Clinical Biomarker and Virology leads within clinical trials.
• Working with an Associate Director to ensure program level operational strategy is deployed within studies assigned.
• Accountable for operational deployment of sample management strategy ensure all activities are completed within time, quality and budget requirements and aligned with agreed program sample management strategy.
• Provide expert input into Clinical Trial documentation including Protocols, Informed Consent Forms, data transfer agreements, lab manuals and central lab specifications to ensure scientific operational aspects are fit for the intended purpose.
• Ensure alignment of biomarker outputs with Data Management, Biostats and modelling/simulation requirements. Provide expert input into data transfer agreements.
• Work with Clinical Operations to draft Site Communications and Training Materials; Train CRO and Internal Teams on sample collection/processing activities as required.
• Accountable for identification, documentation and management of risks within assigned projects with the associated, associate director for the program

This is not intended to be an exhaustive list of responsibilities but rather to be indicative of the role and responsibilities.

Why you?

BASIC QUALIFICATIONS:

• Bachelor's degree in a science or health related discipline
• Experience in: clinical trial specimen management including collection/process of diverse sample types, laboratory management, LIMS and project management
• Knowledge and understanding of the clinical development process, GxP and global regulatory requirements
• Excellent communication skills and good interpersonal and matrix working skills
• Self-motivated with ability to work independently as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team including internal and external technical and business experts

PREFERRED QUALIFICATIONS:

• Master's degree or equivalent experience
• Demonstrated knowledge of Chinese regulatory requirements and expectations for sample analysis including sample exportation
• Experience with validation and implementation of biomarkers

Closing Date for Applications – 22nd October 2024 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.  We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.   

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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