Site Name: UK - Hertfordshire - Stevenage
Posted Date: Oct 11 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
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:
* 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.
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.
Why GSK?
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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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