Clinical Data Lead

工作内容

Site Name: UK - London - Brentford, Belgium-Rixensart, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence, Warsaw Cirrus

Posted Date: Sep 29 2022

Clinical Data Lead

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find Out More

Our approach to R&D   

Job Responsibilities

• Be accountable for the end-to-end Data Strategy & Management (DS&M) study related activities in terms of quality & delivery to plan which include:
• Electronic Case Report Form, vendor data, and other clinical outcome assessments
• Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
• Interim and final cleaned database lock o Archival of all DM documents in the eTMF
• Archival of the study database and provision of clinical data to the study site
• Be responsible for an in-house study, lead the day-to-day DS&M operational study related activities, act as a member of the study core team and be the single point of contact for all the DM study related activities & matters
• Be responsible for study outsourced through a DM Functional Service Provider (FSP), conduct & document DM sponsor oversight of the end-to-end FSP study related activities and ensure training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies.
• Provide DM operational input into the study design, the protocol, study planning, study documents including the study risk register
• Provide reports, status updates, feedback and advice to key study stakeholders on study progress
• Create or review study level timelines for DM deliverables and ensures teams adhere to these
• Promote the implementation of clinical data standards to increase consistency, efficiency & productivity
• Act as the first point of escalation for all DM study issues. Understand, mediate and solve issues related to DM study deliverables and escalate as required to DM representative at Asset level
• Ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
• Develop and maintain excellent professional relationships with study team and other key stakeholders
  

Closing Date for Applications: Friday 14th October2022 (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.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.  If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Why you?

Qualifications & Skills

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

• Bachelor’s Degree, in scientific or business discipline
• Pharma and/or CRO experience.
• Understanding of disease area.
• Understanding of laboratory data.
• Knowledge of medical terminology, anatomy and physiology
• Comprehensive understanding of clinical drug / Vaccine development process
• Good understanding of regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
• Understanding of general data flow & database architecture concepts
• Proficient in Microsoft excel and validation methodology
• Fluent in written and spoken English
• Proven ability to prioritize and multi-task, along with effective time management skills
• Detail oriented and 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
  

Preferred Qualifications & Skills

If you have the following characteristics, it would be a plus:

• Post Graduate Degree in Scientific Discipline
• Experienced in Clinical Data Management processes, standards and clinical systems
• Project Management
• Exposure to InForm, Rave / Veeva / OC, e-Diaries, e-Source
• Basic knowledge of PL SQL, SAS
• CCDM Certification
  

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more: 

Annual Report 2021

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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).

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.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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