Site Name:UK - London - New Oxford Street, Mississauga
Posted Date:Oct 24 2024

Clinical Data Scientist

As a Clinical Data Scientist, you will be responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.

Key Responsibilities:

Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:

o Electronic Case Report Form, vendor data, and other clinical outcome assessments

o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation

o Interim and final cleaned database lock

o Archival of all DM documents in the eTMF

o Archival of the study database and provision of clinical data to the study site

For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters

For study outsourced through a DM Functional Service Provider (FSP), conducts & documents DM sponsor oversight of the end-to-end FSP study related activities and ensures training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies.

Provides DM operational input into the study design, the protocol, study planning, study documents including the studyrisk register

Provides reports, status updates, feedback and advice to key study stakeholders on study progress

Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these

Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity

Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level

Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree, in scientific or business discipline
• Experienced in Clinical Data Management processes, standards and clinical systems

Project Management

Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage

Proficient in Microsoft exce and validation methodology

Basic knowledge of PL SQL, SAS is an added advantage

Understanding of general data flow & database architecture concepts

Good understanding of regulations including ICH-GCP, 21 CRF part 11, CDISC requirement

Comprehensive understanding of clinical drug /Vaccine development process

Knowledge of medical terminology, anatomy and physiology

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

Proven ability to prioritize and multi-task, along with effective time management skills Detail oriented, organized

Excellent interpersonal and teamwork skills

Demonstrates adaptability and an agile mindset

Problem solving mindset

Quick learner

Results oriented and customer focused

Willing to work in a Global environment

Closing Date for Applications: 7th November 2024

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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