Senior Manager, Vaccines Study Delivery, VEO, Open to flexible working
Would you like to be part of GSK's emerging clinical leadership, with an opportunity to accelerate quality efforts across clinical operations on national and global scale? If so, this could be an excellent opportunity to explore.
As a Clinical Study Manager, you will be responsible for leading Global In-Country Clinical operations teams to improve quality processes and evolve the ways of working to optimise clinical operations and foster stronger quality relationships with the sites. You will also support the Director of Quality, Training and Capability Development with all required activities to achieve business goals.
This job within VEO Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of vaccine clinical studies.
- the SDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the development plans, in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines control documents and within regulatory requirements.
- The scope of work includes leadership, study management, oversight and project management of study activities, as well as authorship of some study documents.
- He/she coordinates other functions at a study level, including the Clinical Research Development Leaders (CRDL), Science Leads and GSK Country Medical Directors (for Local studies), who are responsible for the medical and scientific aspects, scientific design of the protocol and scientific outputs including data interpretation and reporting.
- The SDL interacts with other SDLs and VEO to share best practices, lessons learned and support process improvement with participation in working groups as applicable.
This role includes responsibility and/or accountability for the set-up, coordination, execution and delivery of the VEO vaccine portfolio, ensuring the translation of scientific objectives in the Study Management Plan:
- Planning and leading the delivery of vaccine studies to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
- Leadership of a multifunctional matrix team to ensure study oversight, study delivery and takes operational decisions at study level.
- Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
- Accountable for the study delivery strategy and Study Management Plan (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc).
- The SDL ensures functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality. Each study core team member keeps his own accountability to ensure planning and execution of his departmental plans.
- Responsibility and/or accountability to drive assessment, selection, contract development, engagement, and management of appropriate vendors.
- The SDL, in coordination with the study core team, ensures that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements
- The SDL ensures appropriate training of country staff, vendors and sites on protocol and project specific matters - Prepare/deliver monitors meeting (when applicable)
- The SDL develops and ensures on-time execution of supportive documents, plans and manuals including the monitoring plan, communication plan, study procedures manuals, core operational packages for submission and for countries.
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
- The SDL maintains expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the SDL team and beyond
- Supporting technical and leadership development of Study Delivery staff via mentoring and coaching.
We are looking for professionals with these required skills to achieve our goals:
- 6 years of significant experience in managing clinical research studies, clinical operations or equivalent. Has a very good understanding of the clinical research and clinical trial management, 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, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines 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
- Acts 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
- Demonstrates conceptual, analytical and strategic thinking
- Effective at problem solving and conflict resolution
- Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills.
If you have the following characteristics, it would be a plus:
- 2 years of experience in regional clinical study leadership desirable (field experience)
- 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
- Knowledge of French an asset
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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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