Senior Scientific Director at Prime overseeing scientific work and client communication strategies. Leading high - quality delivery and driving business growth in healthcare communications.
About the role
- Monitoring Functional Excellence Lead enhancing Novartis global clinical operations through innovative practices and strategic initiatives. Overseeing adaptive monitoring and ensuring compliance with quality management principles.
Responsibilities
- Leads implementation of functional strategies within assigned programs, including delivery of a data-driven adaptive monitoring approach and proportionate trial oversight.
- Contributes to the development and refinement of field and central monitoring technology tools and templates and support the adoption of processes and governance frameworks for monitoring.
- Support and lead cross-functional change initiatives to improve monitoring performance.
- Manage strategic projects from planning through execution, ensuring stakeholder alignment.
- Act as a champion for monitoring innovation, identifying opportunities for advancements and staying ahead of industry trends.
- Participate in monitoring community forums and working groups to support knowledge sharing and identification of best practices.
- Develop and monitor functional dashboards and KPIs and drive continuous improvement.
- Drive innovation in the use of analytics, visualization, and data-driven techniques to enhance monitoring capabilities.
- Monitor and report on the effectiveness of trial monitoring activities, identifying opportunities for process improvements and driving implementation of enhancements and adjustments with lessons learned.
- Support the organization through the transition to a CM model, including adaptive monitoring, driving cultural and operational change to achieve buy-in and sustained success.
Requirements
- ≥ 5 years of pharmaceutical industry experience
- Proven ability to build strong, effective partnerships with internal and external partners
- Strong knowledge of current regulatory expectations related to clinical trial oversight, including monitoring
- Strong project management, strategic thinking, and stakeholder engagement skills
- Effective influencing, negotiation and conflict resolution skills, with enterprise mindset and demonstrated ability to drive for aligned solutions
- Demonstrable experience in using data and data analyses to provide actionable insights and drive improvement
- Demonstrated experience in innovation for processes, technologies and/or way of working, with a focus on sustainable and scalable solutions.
Benefits
- Health, life and disability benefits
- 401(k) with company contribution and match
- Variety of other benefits
- Generous time off package including vacation, personal days, holidays and other leaves
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