Study Delivery Lead

US or Canadian based - Remote Position

Job Purpose and Key Responsibilities:

This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams.

Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.

Essential behaviors valued include continuous improvement and learning, effectiveness at building networks of partners and stakeholders, and ability to lead and inspire others. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.

Details:

This position may contribute to individual studies in addition to project level activities, as appropriate, including responsibility and/or accountability for the set-up, coordination, execution and delivery of one or more studies, programs, or groups of programs from one or more therapy areas in vaccines, specifically:

• The delivery and quality of all clinical studies from protocol concept to final study report and for the validity of all data originating from studies supporting their portfolio.
• Reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing.
• Compliance with ICH/GCP guidelines, 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 project; takes action to mitigate risk where appropriate.
• Requires 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.

Why you?

Basic Qualifications:

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

• Bachelor's degree in the areas of General Science or Life/Health Science
• 6 years of experience in managing clinical research studies, clinical operations or equivalent

Preferred Qualifications:

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

• Extensive experience within the pharmaceutical industry or CRO environment in clinical operations
• Experience of leading study teams
• Experience in study management, global regulatory guidelines and ICH/GCP
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
• Experience working with investigators, external experts, Contract Research Organizations and vendors
• Broad understanding of the pharmaceutical industry and the clinical development process
• In depth knowledge of either study management or data management and knowledge of essential regulatory guidelines worldwide and GSK company policies.
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
• Excellent influencing and negotiation skills.
• Advanced degree in life science or related field (e.g., MS, PhD, PharmD) or equivalent experience
• Experience leading global study teams
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
• Excellent leadership skills.
• Demonstrated experience leading matrix environment to deliver projects, develop clinical plans, and manage change

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​

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With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​

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Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​

*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.

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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

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