GlaxoSmithKline Vaccine Clinical Development Manager in Wavre, Belgium
This job within VEO (Value Evidence & Outcomes) Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of vaccine Value Evidence human subject research (HSR) and non-human subject research studies and projects acting as a Study Delivery Lead (SDL).
This role includes responsibility and/or accountability for the set-up, coordination, execution and delivery of the VEO human subject research and non- human subject research studies and projects:
You plan and lead the delivery of vaccine studies and projects to time, quality, budget, company standards and scientific requirements from concept protocol/project specifications to final study report/final deliverables.
You are accountable for coordination and delivery of a fully feasible Study Protocol/project specifications, when relevant Informed Consent Forms, operationally robust study/project documentation and Study Reports.
You ensure document management and quality. Responsibility and/or accountability to drive contract development, engagement, and management of appropriate vendors if required.
You ensure appropriate training of vendors on protocol and project specific matters.
You develop and ensure on-time execution of supportive documents as needed.
You make decision which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
You maintain expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the SDL team and beyond
You are accountable for the End to End process of contracting including Third Party Oversight plan
You are accountable to ensure the study/project registration in the appropriate tracking system as well as uploading the expected documentation
You are accountable to ensure the study/project is managed and up to date in the tracking system until its closure.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals:
3 years of significant experience in managing research studies preferably HEOR/Epidemiology or Clinical, clinical operations or equivalent. Has a good understanding of clinical trial management or non-interventional research, associated regulatory, processes and quality requirements.
Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
Demonstrates an excellent understanding of the clinical study and research practices, and other associated process and quality requirements, including CIOMS and SOPs
Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
Able to set and manage priorities, performance targets and project initiatives in a global environment
Operational expertise in risk management and contingency planning
Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency
Act as role model in line with GSK Vaccines core values and Expectations
Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK Vaccines systems/software
Demonstrate conceptual, analytical and strategic thinking
Effective at problem solving and conflict resolution
Possesse excellent English language written and verbal communication skills in addition to proven negotiation skills. Knowledge of French an asset
If you have the following characteristics, it would be a plus:
2 years of experience in HEOR/Epidemiology study leadership desirable (field experience)
Proven expertise in the proactive identification of issues which may impact research programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
Knowledge of French an asset
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes 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 genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing . So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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