Clinical Research Associate

BeiGene, Ltd.; Lombardia; On-site; EUR 45,000 - 56,000; Full time

Job summary

BeOne Medicines seeks a Clinical Research Associate to monitor oncology/hematology trials in Italy, ensuring ICH-GCP compliance and adherence to BeOne SOPs. You will perform pre-study, initiation, routine monitoring and closeout visits, coordinating with the Regional Clinical Operations Manager to keep milestones on track.

Requires a BS in a scientific field and 2+ years of monitoring experience; oncology experience preferred.

Qualifications

• BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
• Experience in oncology global trials preferred.
• Fluent in English and Italian (writing and speaking).

Responsibilities

• Perform site monitoring visits per ICH-GCP and SOPs.
• Collaborate with Regional Clinical Operations Manager to meet study milestones.
• Identify gaps and propose CAPA and improvements.
• Ensure trial readiness and regulatory submissions tracking.
• Provide protocol and study training to sites.

Skills

Communication

Interpersonal skills

Organizational skills

Multitasking

Analytical thinking

English & Italian fluency

Education

BS in a relevant scientific discipline

Tools

Microsoft Word

Excel

MS Project

Outlook

Job description

General Description:

The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region. The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained. Identify gaps and areas for improvement and propose CAPA. Supports start-up and provides local expertise. The CRA activities include performing feasibility, site identification, selection and evaluation, supporting the initial list of sites and recruitment targets. Provides protocol and related study training to assigned sites. Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs). Conducts co-monitoring visits, if required. Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP. Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Establishes regular lines of communication with sites and reports site progress, issues and proposed actions to Clinical Operations. Ensures inspection readiness of the study and sites. Collaborates with the Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.). Attends disease indication project specific training and general CRA training as required. Facilitates Study Oversight Visits (SOVs), site audits and/or inspections, as required. Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. Anticipates and identifies site issues; proposes corrective and preventative actions; identifies gaps and utilizes opportunities. Constantly strives for operating excellence, questions status-quo, and promotes innovation.

Education Required:

BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.

Experience in oncology global trials preferred.

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
• Experience in oncology/hematology trials preferred
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English & Italian (writing and speaking)

Computer Skills:

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.

Travel:

Up to 60%.

Salary Range EU:

44,800.00 EUR - 56,000.00 EUR.

Global Competencies:

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Equal Opportunity Statement:

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.

About BeOne:

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them.

Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit