Site Monitoring Lead (SML) sponsor dedicated in Germany

Overview

Site Monitoring Lead (SML) sponsor dedicated in Germany responsible for site management oversight, clinical monitoring deliverables, and central monitoring activities with a focus on patient safety, compliance, and data integrity.

What you'll do

• Oversee site interactions post activation through site closeout.
• Manage clinical monitoring and central monitoring deliverables for patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Identify and mitigate risks related to protocol execution and the completion of the Risk Assessment and Categorization Tool (RACT).
• Review study scope of work, budget, and protocol content and communicate contractual obligations to the clinical project team.
• Escalate risks and out-of-scope requests to the project manager and propose risk mitigations.
• Serve as an escalation point for communications with investigator site staff and may interact with sites by phone or in person.

What you'll need

• Have a Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Demonstrate ability to lead and align teams to achieve project milestones.
• Demonstrate capability working in an international environment.
• Show expertise in site management and monitoring (clinical or central).
• Demonstrate understanding of clinical trial management financial principles and budget management.
• Demonstrate knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Demonstrate good computer skills and strong conflict resolution skills.

Details

• Role is for Germany and may require moderate travel (~20%).