Beschreibung

In this home-based role, you will drive the success of medical device trials by managing site visits and ensuring regulatory compliance while mentoring colleagues and collaborating with clinical experts.

Anforderungen

• •Degree in life science, scientific discipline, or healthcare apprenticeship
• •Two years on-site monitoring experience or equivalent combination
• •Preferred experience in medical devices trials
• •Knowledge of GCP and ICH guidelines
• •In depth knowledge of ISO 14155
• •Strong communication skills and attention to detail
• •Fluency in German and good English command
• •Flexibility for business travel up to 50%
• •Strong IT skills and Microsoft Office proficiency
• •Preferable driver’s license class B

Aufgaben

• •Perform site selection and initiation visits
• •Conduct monitoring and close-out visits
• •Monitor medical device clinical trials
• •Support subject recruitment plan development
• •Evaluate site practice quality and integrity
• •Ensure compliance with GCP and ISO 14155
• •Track regulatory submissions and recruitment progress
• •Manage CRF completion and data queries
• •Collaborate with site experts and clients
• •Mentor less experienced team members
• •Act as a subject matter expert

Tools & Technologien

Benefits