Senior Clinical Research Associate

This is a fully remote position, open to applicants in Germany.

📋 Description

• Ensure the appropriate execution of clinical trials in line with the Study Monitoring Plan and relevant laws, as well as Good Clinical Practices.

• Oversee the operational elements associated with the implementation of clinical trial activities at designated investigator sites, from site activation through to database lock, ensuring that timelines and quality deliverables are achieved.

• Collaborate with the study team as necessary, facilitating the flow of information among study team members, vendors, and designated investigator sites.

• Monitor site-level Adverse Events (AEs) and Serious Adverse Events (SAEs), collaborating with the Drug Safety Unit and following up with investigator sites, as required, to ensure SAE reports are resolved with the necessary information.

• Act as a primary contact for audit management, driving the development of Corrective and Preventive Actions (CAPA) for Audit Observations, when applicable.

⛳️ Requirements

• Bachelor’s degree in life sciences or a professional qualification in life sciences such as nursing, pharmacy, medical background, or an equivalent field.

• Comprehensive understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• A minimum of 3.5 years of relevant experience in clinical research site monitoring, preferably in the field of Oncology.

🏝️ Benefits

• Health insurance

• Retirement plans

• Professional development opportunities