BeOne Medicines I GmbH is hiring a Clinical Research Associate

BeOne Medicines I GmbH seeks an experienced Clinical Research Associate responsible for executing clinical monitoring activities at trial sites. You will monitor oncology/hematology clinical trials in accordance with ICH guidelines, GCP, local regulations, and applicable SOPs to ensure timely study completion within your assigned region.

What You'll Do

• Execute clinical monitoring activities at clinical trial sites.
• Monitor clinical trials in accordance with ICH guidelines, GCP, local regulations, and applicable SOPs.
• Perform monitoring activities related to site selection, initiation, conduct, and timely completion of oncology/hematology clinical trials.
• Collaborate closely with the Regional Clinical Operations Manager to maintain study timelines and quality standards.
• Identify gaps and areas for improvement and propose corrective and preventative actions.
• Support start-up, provide local expertise, and perform feasibility, site identification, selection, and evaluation.
• Provide protocol and related study training to assigned sites.
• Conduct pre-study, initiation, routine monitoring, and closeout visits per the monitoring plan and SOPs.
• Complete monitoring visit reports according to ICH-GCP, company standards, and SOP.
• Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
• Establish regular communication with sites and report progress, issues, and proposed actions to Clinical Operations.
• Ensure inspection readiness of the study and sites.
• Collaborate with the Regional Clinical Operations Manager and sites to ensure timely delivery of study milestones.
• Attend disease-specific and general CRA training as required.
• Facilitate Study Oversight Visits, site audits, and inspections as required.
• Evaluate the quality and integrity of site practices, escalating quality or GCP issues appropriately.
• Anticipate and identify site issues, propose solutions, and utilize opportunities.

What We're Looking For

• BS in a relevant scientific discipline.
• Minimum of 2 years of monitoring experience.
• At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry.
• Thorough understanding of clinical trial processes and knowledge of ICH and associated regulatory guidelines.
• Excellent communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multi-task.
• Fluent in English & Italian (writing and speaking).
• Proficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook.

Nice to Have

• Experience in oncology global trials.
• Experience in oncology/hematology trials.
• Site start-up (SSU) experience.

Technical Stack

• Microsoft Word
• Excel
• MS Project
• MS PowerPoint
• Outlook

Team & Environment

You will collaborate closely with the Regional Clinical Operations Manager.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.