Senior Clinical Research Associate – Sponsor Dedicated

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

📋 Description

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

• Oversee the operational elements for the implementation of clinical trial activities at designated investigator sites from site activation to database lock, ensuring adherence to timelines and quality deliverables.

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

• Monitor site-level AEs and SAEs, working in conjunction with the Drug Safety Unit and following up with investigator sites, as needed, to ensure the resolution of SAE report information.

• Act as a primary contact for audit execution and lead the development and verification of Audit Observation CAPA, when applicable.

⛳️ Requirements

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

• In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country regulations.

• At least 3.5 years of pertinent experience in clinical research site monitoring, ideally within Oncology.

• Preferred therapeutic background in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

🏝️ Benefits

• Health insurance

• Professional development opportunities