Job ID290134BRPosition TitleGlobal Head, Clinical Trial Management COEApply to Job
Job Description
With over 400 active trials in 5 hub countries, Novartis GDO Trial Management feels privileged to bring together and manage all aspects of clinical trial operations reaching around 50 000 patients worldwide. We are a proactive learning organization and we place a lot of emphasis on collaboration and individual development. As part of this we are very committed to evaluating the latest digital technologies, always looking to transform trials and improve lives. TM is in search of those who are passionate about applying their experience to reimagine clinical trial operations and ultimately improve the lives of our team, our organisation and our patients.
As our Global Head, Clinical Trial Management COE, you will develop and maintain a center of excellence for trial support activities that builds organizational capabilities and drives more efficient and cost effective delivery across Trial Management. You will understand trends, best practices, internal/external factors to be able to proactively lead capability building and strategic initiatives which ensure optimized operations and highest level of quality. You will collaborate on the development and implementation of process standards and tools to achieve excellence in trial operations and management. Additionally, you will ensure Audit readiness for Trial Management and be the owner of the Quality Plan for Trial Management.
Your responsibilities will include:
• Lead team to develop functional center of excellence in area of responsibilities by identifying and implementing best-in-industry practices.
• Ensure high performance of Process Control Manager (PCM) group responsible for the implementation of enhanced quality systems and standards within Trial Management. Build this group across Franchises.
• Lead training team to create, design and implement capability building strategy for the Trial Management organization. Perform competency and skill assessments in conjunction with internal/external factors and trends to provide input on required training to Global Development University or develop specific training programs for the needs of the organization to improve the medical/scientific, operational and budget management capabilities as appropriate for associate’s role.
• Develop and implement process standards and tools to achieve excellence in trial operations and management. In collaboration with the Director of Operations and key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance within GDD across compounds and projects. Including but not limited to ADVANCE/NCDS and J-Review training for study leads, clinical study report training, clinical data reconciliation principles, and others as assigned.
• Responsible for the tracking progress to Key Quality Indicators (KQIs), Quality Plan and overall compliance to applicable processes and regulations.
• Collaborate closely with DOS compliance governance team to ensure standardization in approach and coordinated compliance management.
• Support on-boarding, training and mentoring of new associates across Trial Management to accelerate performance. Identify tools, resources, platforms to enhance the collaboration and effectiveness of associates in Trial Management.
• Build best talent and an empowered culture within team to foster high performance in a matrix environment. Sponsor key talents across the organization to ensure business critical roles and talent continuity across Trial Management.
• Advanced degree or equivalent education/degree in life science/healthcare required (PhD/MD Preferred).
• Fluent English (oral and written)
• ≥15 years of pharmaceutical clinical drug development experience.
• ≥15 years people management incl. leadership of managers and talent development experience required, this may include management in a matrix environment. Global people management required.
• Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
• Strong management, interpersonal and problem solving skills.
• Extensive knowledge of clinical development process, regulatory requirements and GCP. Novartis experience in these areas is preferred.
• Proven track record in clinical operations process improvements.
• Consistent track record in developing and implementing training and development strategy.
• Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: talentnetwork.novartis.com/networkDivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
