Study Delivery Lead - Stevenage, United Kingdom - GlaxoSmithKline

Description

Site Name: UK - Hertfordshire - Stevenage

Posted Date: Mar

Study Delivery Lead - Value, Evidence and Outcomes (VEO), Vaccines

Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for you

In Value, Evidence and Outcomes (VEO), we lead a wide variety of studies to support the development and reimbursement of GSK's innovative medicine portfolio. The VEO family is made up of Value Evidence scientists, epidemiologists, patient centred outcomes scientists, patient focussed development leads, data analysts and modellers, as well as critical support functions of study delivery, project management, quality, and business operations who work together to deliver an expanding portfolio. We currently have open positions in VEO Study Delivery for the right candidates.

This role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies. The types of studies run by VEO include:

• Interventional studies
• Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g., with EMRs/chart abstraction), patient reported outcomes development and validation
• Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence/incidence studies of exposure, risk factors and outcomes
• Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients
• Economic modelling studies and supplemental analyses of clinical trials/meta-analyses

In this role you will

• Take responsibility and/or accountability for the set-up, coordination, execution, and delivery of the VEO portfolio in partnership with the Science Lead, with responsibilities including but not limited to:
• Planning and leading the delivery of VEO studies to timelines, quality, budget, company standards and scientific requirements; from concept protocol to final study report
• Oversight, coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports
• Accountability for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc)
• With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors
• Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies
• Making decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate
• Working with matrix partners, Study Delivery Therapy Area Lead and/or manager to develop and manage study level budget within project budget allocation
• Active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills

Closing Date for Applications: April 12th, 2023 (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 This will help us to understand any modifications we may need to make to support you throughout our selection process.

#LI-GSK

Why you?

Qualifications & Skills:

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

• Bachelor's degree in life sciences or related discipline
• Broad understanding of the pharmaceutical industry and the clinical development process
• Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
• Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
• Excellent leadership skills
• Excellent influencing and negotiation skills

Preferred Qualifications & Skills:

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

• In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide
• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
• Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change
• Experience in managing relationships with vendors to ensure successful delivery of projects

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

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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