Senior Clinical Research Associate Line Manager

BeOne Medicines is growing rapidly, offering experienced professionals challenging opportunities to fight cancer. We seek scientific and business leaders who are highly motivated, collaborative, and share our passion for cancer research.

Overview

Acts as line manager for study start‑up and trial monitoring staff (CRAs) in the country.

General Description

Manages study start‑up and trial monitoring staff: planning, assigning, directing work, assessing performance, guiding professional development. Participates in hiring selection and resource allocation for clinical research projects, assigning staff based on experience and training. Demonstrates high level of clinical operations knowledge, organizational skills, project management and leadership competencies. Ensures adherence to ICH/GCP, local regulations, applicable SOPs and that clinical trial protocols are executed at sites accordingly. Collaborates closely with the Regional Clinical Operations Manager to maintain study timelines and required quality standards. Provides local expertise to support study start‑up.

Essential Functions

• Manages study start‑up and trial monitoring staff in accordance with BeOne’s policies and applicable regulations.
• Participates in hiring new employees, ensuring proper onboarding and training, overseeing execution of training plans.
• Manages quality of assigned staff’s clinical work through regular review and evaluation.
• Provides country‑specific start‑up expertise to team leads and projects; reviews study start‑up documents, drug labels, ICF and other applicable documents.
• Helps develop and review site‑specific recruitment materials and tools.
• Performs independent quality review of submission packages, submits packages to EC and HA as required.
• Collaborates with Regional Clinical Operations Manager and clinical study sites to achieve timely IRB/EC submissions, TMF completeness, site activation and enrolment goals, and inspection readiness.
• Contributes to feasibility, site identification, selection and evaluation.
• Performs accompanying visits of CRAs to assess performance, reviews visit reports, follows up on issue resolution and communicates significant risks to the Regional Clinical Operations Manager.
• Ensures staff meet defined workload and quality metrics through regular review and reporting.
• Anticipates and identifies site issues; proposes CAPAs; identifies gaps and utilizes opportunities to promote operating excellence and innovation.
• Contributes to Clinical Operations strategy and performance against key metrics, identifying improvement areas and proposing solutions.

Supervisory Responsibilities

• Mentor and manage junior staff and Clinical Research Associates.
• Acts as escalation point for CRAs with site‑related issues and concerns.
• Conducts mid‑year and year‑end performance appraisals for direct reports, providing constructive feedback and overseeing subordinate team performance.

Education Required

• Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline.
• Minimum of 5‑7 years progressive experience in clinical operations within the biotech/pharmaceutical sector in Italy.
• Prior clinical trial experience, including management/leadership capacity, preferably in oncology.

Computer Skills

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

Other Qualifications

• Ability to work independently and effectively handle multiple priorities in a fast‑paced environment.
• Minimum of 5‑7 years progressive experience in clinical operations, including at least 2 years of line management in pharmaceutical or CRO industry.
• Excellent interpersonal and organizational skills.
• Fluent in English (written and spoken).

Travel

Up to 30‑40%.

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

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.