Senior Clinical Research Associate, CRA

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

📋 Description

• Oversee the management and monitoring activities at clinical trial sites, ensuring adherence to GCP guidelines, relevant regulations, and standard operating procedures (SOPs).

• Carry out clinical monitoring tasks, which include site qualification, initiation, routine monitoring, and the closing of visits.

• Maintain the Investigator Site Files and Trial Master Files diligently.

• Execute site management activities in accordance with trial-specific functional plans.

• Generate precise and timely reports following site visits.

• Assess trial progression (e.g., patient recruitment, data collection, resolution of issues) and take suitable actions as needed.

• Act as the main point of contact for clinical trial supplies and liaise with relevant stakeholders or vendors.

• Engage in meetings with the clinical trial team, department, and the company.

• Assist in the creation of trial-specific documentation.

• Support the ongoing enhancement of Clinical Operations processes and procedures.

⛳️ Requirements

• A Bachelor’s degree in life sciences, nursing, or a related field.

• A minimum of 2 years of experience in on-site monitoring (including all visit types) within the pharmaceutical or biotechnology sector.

• Comprehensive knowledge of ICH-GCP, relevant regulations, and clinical trial systems (e.g., eTMF, CTMS, EDC, IRT).

• A basic understanding of oncology, including its terminology and fundamental science, is preferred.

• Exceptional presentation and communication abilities in both German and English (minimum C1 level).

• Willingness to travel up to 50-75% of the time.

🏝️ Benefits

• Job bike.

• Job ticket.

• Health programs.

• Childcare benefits.

• Relocation allowance.

• Company summer and winter events.