Manager, Monitor-Hybrid

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

The Central Monitoring and Risk Management is at the heart of Abb Vie’s end-to-end RBQM model—a critical pillar required in Abb Vie’s mission to be a world-class R&D organization.

The Central Monitoring Manager I is responsible for managing a cohesive team of front-line central monitor staff to deliver best-in-class central monitoring execution. They ensure central monitoring in clinical research studies are executed on-time with quality and efficiency, ensure that the strategies and tools selected are implemented appropriately, and ensure best practices are maximized to drive execution. They are responsible for managing processes/programs in multiple countries and across multiple Therapeutic Areas.

They will ensure an inclusive, learning, and innovative environment that sets up central monitors and their assigned studies for success.

The Central Monitor function is de-centralized and includes team members from across the globe. Central Monitor Managers are responsible for staff across the globe.

Responsibilities:

• Delivering on best-in‑class central monitoring, while driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.
• Partnering with study teams to drive the implementation of the aggressive execution strategies
• Line management of Central Monitors. Resourcing, development of high performing teams, contracting, budgeting, hiring, performance reviews, and leading talent development of staff, including linking the “why” and bigger picture, elevating team to think more strategically, creating a culture of challenging the status quo to drive efficiencies and innovation, bringing ideas from outside of Abb Vie, inspiring the team, and creating an inclusive and supportive environment in which staff are empowered to achieve peak performance.
• Utilizes deep understanding of central monitoring and risk evaluation to support front‑line staff and strength in influencing/partnering to build trust with Clinical Site Management, Clinical Development Operations (CDO) and cross‑functional stakeholders.
• Contribute to ongoing development/advancement/improvement of the RBQM systems – providing requirements that will further enable near‑real time data analysis to ensure quality.
• Be an RBQM and champion across Abb Vie, supporting the execution of RBM processes as part of cross‑functional teams spanning the R&D portfolio (all therapeutic areas and phases of development). Advises when updates are needed.
• Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of programs and protocols
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.

Education & Experience

• Bachelors degree in related field, may include life sciences, risk-based discipline.
• Minimum of 6 years of clinically related experience or data trend analysis experience, 4 years is required in study operations with some people management experience (remote experience preferred).
• Experience working in an RBQM-model or similar experience with…