An exciting opportunity to join our risk-based monitoring team. Risk-based monitoring (RBM) is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes that have the most potential to impact patient safety and data quality. In this context, the RBM team is responsible for designing, executing, and optimizing the Sanofi RBM approach to align with regulatory requirements and Sanofi's objective to drive quality, efficiency, and speed of clinical trials.
The Central Monitor Lead is responsible for leading the signal manager team. As a key driver of our risk-based management strategy, you will ensure the end-to-end risk-based management activities delivery for all selected studies to safeguard data quality, patient safety, and trial reliability. You will also influence the operation team to implement an adaptive monitoring strategy and facilitate the efficient and effective performance of the site monitoring activities. An exciting innovative role to foster the clinical trial transformation.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
Team Leadership: 1)Direct a team of Signal Managers, fostering a collaborative matrix structure that enhances productivity and innovation. 2)Conduct training, mentoring, engagement, development, and recruitment for the signal manager team, fostering a culture of excellence and continuous learning.
Performance and Delivery: 1) Define and execute the RBM signal management strategy. 2)Oversee and participate in central monitoring activities for assigned studies, ensuring adherence to best practices and regulatory standards. 3)Optimize Signal manager resource allocation to meet project demands and organizational goals.
Process Improvement: 1)Champion continuous improvement initiatives for internal RBM processes, and 2) Refine the monitoring approach, including but not limited to monitoring approach, Source Data Verification (TSDV), Source Data Review(SDR)
Stakeholder: 1) Represent Signal manager in transversal projects and programs, liaising with internal and external stakeholders to align objectives and strategies. 2)Maintain an effective relationship with the Global RBM team with an end objective to ensure regulatory compliance and reliability of the clinical trial results.
Experience: Experience in trial operation or data management or quality management.
Familiarity with clinical research regulatory requirements, including ICH GCP guidelines especially for risk-based monitoring methodologies.
Proficiency in data analysis and providing actionable insights.
Soft and technical skills: Strong Project management skills.
Effective leadership and people management skills.
Be able to learn and adapt quickly.
Good interpersonal, communication, and presentation skills.
MS Office- Excel, Word, PowerPoint & SharePoint.
Able to review or learn to use the business intelligence dashboard.
Education: Bachelor’s degree or above, preferably in life science (or equivalent)
Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks of gender-neutral parental leave.
An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
A team that drives the innovation of the monitoring activities that align with future need
“Our Central Monitor Lead is a strategic visionary who is charting the path for a risk-based approach that propels our clinical monitoring practices into the future. You'll have the unique opportunity to shape the future of our clinical monitoring practices, to drive continuous improvement, and to mentor a dynamic team that is committed to excellence.”
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.