Site Name: UK - London - Brentford, RTP
Posted Date: Sep
Are you a proven Clinical Study Manager with operational credibility, demonstrated ability to input to and influence studies/projects through operational expertise, and demonstrated excellence in stakeholder management? If so, then this position could be a perfect fit for you!
We are currently seeking a Clinical Global Study Delivery Lead to join the team on a permanent, full-time basis. As the successful candidate, you'll be responsible for the global set-up, coordination and delivery of Investigator Initiated Studies (IIS) and Supported Collaborative Studies (SCS) from the Respiratory and Immunology area, specifically this will involve:
- Proactively managing end to end study delivery for IIS and/or SCS, providing operational support for delivery of assigned studies ensuring they are conducted in accordance to GSK SOPs, relevant legislation, on time and within budget from concept to completion.
- Working with the GSK supplies team/s to manage commercial and clinical supplies.
- Working with the finance team/s to effectively forecast budget, track invoicing/payments and track actual spend.
- Partnering to complete contracting activities such as due diligence and ABAC checks.
- Study timeline and milestone management.
- Manage end to end KPI reporting internally on individual study status.
In this role you will
- Be the operational point of contact for the external Study Sponsor and Internal Stakeholders:
- Be the primary point of contact with SS Coordinators and other key stakeholder groups including data management, safety, biostatistics, legal, compliance, project management.
- Facilitate engagement between Sponsor and GSK scientific and contracting teams as required
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
- Interact and build strong relationships with Country Local operating company, MSLs and matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
- Interact effectively across boundaries with other global functions using influencing and relationship-building skills and working together to overcome issues as required.
- Provide regular progress updates to key stakeholders and escalate issues as required.
The position may also include:
Leading and driving significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Being responsible for implementing new business processes and strategies.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree or equivalent in Life Sciences or related field.
- Previous solid hands-on experience working in clinical operations.
- Experience of working in academic partnerships and/or external alliances with proven clinical project or alliance management skills.
- Proven ability to build and nurture relationships with a range of stakeholders.
- Demonstrated awareness of the principles of quality, safety, risk management and compliance (ICH and GCP).
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Advanced degree (e.g., MS, PhD, PharmD) or equivalent experience.
- Experience of Respiratory and Immunology Drug Development.
- Excellent leadership skills.
Closing Date for Applications: Friday 7th October 2022 (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.
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
R&D
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
LI-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. 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 , or send an email
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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