Clinical Trial Managers (SMLs) sponsor dedicated in Germany

Overview

Clinical Trial Manager (SML) role for a single sponsor partnership in Germany, focused on site management oversight, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, protocol/GCP/regulatory compliance, and data integrity.

What you'll do

• Oversee site interactions post-activation through site closeout.
• Manage clinical monitoring and central monitoring deliverables.
• Review and provide risk mitigation for critical data and process risks across protocol execution.
• Coordinate delivery handoffs with Study Start Up, Patient Recruitment, and Data Management to meet study milestones.
• Ensure clinical study tools/templates are developed and maintained, including the Clinical Monitoring Plan.
• Review monitoring documentation quality to reflect site management activities and patient safety/data integrity.
• Provide status updates and escalation support for risks and out-of-scope items.

What you'll need

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Ability to lead and align teams toward project milestones.
• Capability to work in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Demonstrated strong conflict resolution skills.
• Good computer skills.

Details

• Location: Germany (ATS: DEU-Remote).
• Moderate travel may be required, approximately 20%.