Site Monitoring Lead (SML) sponsor dedicated in Germany

In this Site Monitoring Lead role, you oversee site management, clinical and central monitoring with a focus on patient safety, compliance, and data integrity in Germany. You’ll guide cross-functional teams, manage risk and ensure study milestones are met, from activation to closeout. You’ll interact with investigators, coordinate with TP group leaders, and support readiness for inspections. This position offers impact across oncology trials and a fast-moving clinical environment.

• Oversee site management, monitoring deliverables, and data integrity from activation to closeout
• Identify and mitigate risks using RA CT tool and monitoring plans
• Review study scope, budget, and protocol content to align with contractual obligations
• Escalate risks to project management and ensure adherence to timelines, quality, and budget
• Coordinate training, resourcing, and study team conduct; manage CRAs and Central Monitors
• Review and maintain CTMS, dashboards, UAT, and other systems; ensure audit trails
• Provide status updates to clients and leadership; propose solutions to obstacles in protocol execution
• Contribute to development of monitoring strategies, CMP/SMP, and risk plans
• Mentor and coach CTMs and monitoring staff; support data cut and lock deadlines
• Ensure compliance with GCP/ICH and regulatory requirements; support inspections

• Bachelor’s degree or RN in a related field or equivalent
• Proven ability to lead teams to milestones in an international environment
• Expertise in site management and clinical/central monitoring
• Experience with risk-based monitoring is preferred
• Understanding of trial management finance and budgets
• Knowledge of GCP/ICH and regulatory requirements
• Strong computer and data management skills
• Excellent conflict resolution and problem-solving abilities
• Ability to travel up to ~20%
• Experience in oncology is a plus

• conflict resolution
• problem solving
• leadership and mentorship
• site management and monitoring (clinical or central)
• risk assessment and mitigation
• CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS