Clinical Site Management Excellence Lead (all genders)

Overview

In this role you drive strategic and operational excellence in clinical trial monitoring and site management, ensuring global harmonization and inspection readiness. You shape how monitoring and site activities execute the overarching clinical strategy across activation, initiation, monitoring, escalation, CAPA, and close-out. You collaborate with regional, global, CROs and vendors to enable scalable, compliant processes and modern trial delivery. You join a multicultural, inclusive environment focused on advancing patient care through science and technology.

Responsibilities

• Lead planning, execution, and oversight of clinical trial monitoring and site management
• Harmonize monitoring practices globally and ensure inspection readiness
• Define and implement site management to operationalize the monitoring strategy from activation to close-out
• Coordinate cross-functional interactions at country, regional, and global levels with study teams, CROs, vendors, and other interfaces
• Partner with Regional/Cluster Heads and GDO/R&D peers to shape scalable, compliant processes
• Act as internal consultant driving transformation and improvement in GCP-compliant processes
• Align processes with regulatory expectations and organizational objectives
• Translate performance metrics into targeted process improvements and tool adoption
• Support risk-based monitoring, decentralised/remote monitoring, and digital health integration through process design
• Travel up to 20% to support global trial delivery

Key requirements

• Advanced degree in Life Sciences, Medicine, Clinical Research, or related field; or equivalent experience
• 12+ years in clinical research with deep site management and clinical monitoring expertise
• Proven track record owning end-to-end clinical processes (design, documentation, oversight, continuous improvement) in a regulated setting
• Strong knowledge of ICH-GCP guidelines, including ICH E6(R3)
• Experience applying Quality by Design and risk-based quality management
• Led cross-functional initiatives in complex matrix organizations without direct authority
• Partnered with technology/digital teams to define system requirements and enable tool adoption
• Data-driven approach to translate metrics into process improvements
• Willingness to travel internationally up to 20%

• Cross-functional collaboration
• Strategic thinking and influence
• Effective communication and stakeholder management
• ICH-GCP incl. E6(R3)
• Quality by Design
• Risk-based monitoring

…