Senior Manager, Site Management

BeOne Medicines; Kuala Lumpur; On-site; MYR 180,000 - 280,000; Full time

Benefits offered by this job

Bonus program

Company shares

L&D opportunities

Benefits program

Job summary

BeOne Medicines seeks a Senior Clinical Research Manager in Kuala Lumpur to oversee clinical monitoring activities and guide the CRA team, ensuring compliance with ICH‑GCP, local regulations, and company SOPs. This role leads a high‑performing team and promotes a positive collaborative culture.

The position requires 7+ years in pharma/CRO, 4+ years of people or project management, strong English, and oncology experience.

Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline.
• 7+ years industry experience in pharma/CRO or related field.
• 4+ years people or project management in clinical research.
• Strong knowledge of ICH-GCP and health authority requirements.
• Experience as a CRA or monitoring/trial execution preferred.
• Excellent communication and leadership skills.

Responsibilities

• Allocate CRA resources and balance workload for quality monitoring.
• Ensure CRAs have monitoring knowledge to meet deliverables.
• Manage CRA performance and quality indicators per ICH‑GCP and SOPs.
• Strengthen site relationships to improve performance.
• Review monitoring quality and ensure regulatory compliance.
• Lead study/site milestones with cross-functional teams.
• Oversee assessment visits and CRA competency evaluations.
• Contribute to process optimization and risk management.
• Support site audits and corrective actions.
• Review expenses related to CRA activities.
• Identify cost-saving opportunities while maintaining quality.
• Mentor junior CRMs and provide development opportunities.
• Drive strategic initiatives in clinical operations.

Skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Outlook

Leadership

Project management

Clinical research

Oncology experience

English proficiency

Education

Bachelor’s degree or higher in a scientific or healthcare discipline

Job description

Job Description

General Description: The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH‑GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture.

Essential Functions Of The Job

• Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables.
• Ensure CRAs have the required level of monitoring knowledge and skills to successfully perform required activities with high quality to meet study deliverables.
• Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH‑GCP, SOPs and local regulations.
• Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation.
• Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH‑GCP Guidelines, and Good Clinical Practices.
• Support study/site milestone delivery in collaboration with cross‑functional teams.
• Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies.
• Contribute to process optimization initiatives and manage risk escalation and resolution.
• Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow‑up for identified issues.
• Review and approve expenses related to CRA activities to ensure alignment with applicable policies and financial best local practices.
• Identify opportunities for cost‑saving and efficiency while maintaining quality and compliance standards.
• Provide mentorship and guidance to junior Clinical Research Managers (CRMs), supporting their professional growth and development if required.
• Facilitate learning opportunities and provide valuable insights and feedback to help upskill and promote consistency within the wider team.
• Lead and contribute to strategic initiatives and task forces aimed at improving clinical operations processes and outcomes, driving projects from inception to completion in alignment with organizational goals and in collaboration with cross‑functional teams.

Supervisory Responsibilities

• Recruitment and onboarding: performs recruiting and hiring activities, along with onboarding new team members to ensure alignment with team objectives and culture.
• Task assignment: assigns tasks based on individual strengths and team objectives, ensuring optimal productivity.
• Support and resource provision: supports team members by providing necessary resources to help them effectively perform their roles.
• Communication and collaboration: encourages open communication and collaboration within the team and with other functions, including acting as a point of contact for issue escalation and feedback where required.
• Performance evaluation: conducts regular performance evaluations and provides constructive feedback to promote continuous improvement.
• Mentoring and development: leads and mentors team members, fostering an environment of growth and development.
• Issue resolution: addresses any personnel issues promptly and fairly to maintain a positive work environment.
• Career development support: supports team members in identifying and pursuing professional development opportunities.

Qualifications

• Education: Bachelor’s degree or higher in a scientific or healthcare discipline; advanced degrees preferred.
• Computer skills: proficient in Microsoft Word, Excel, PowerPoint and Outlook.
• Fluent in written and verbal English.
• Minimum 7 years of industry experience in the pharmaceutical or CRO or relevant field.
• Minimum 4 years of people management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred.
• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH GCP) and health authority requirements.
• Understanding of all aspects of monitoring and trial execution, with previous experience as a CRA preferred.
• Excellent interpersonal skills, strong organizational and effective written and verbal communication skills. Demonstrated team leadership experience.
• Experience in oncology is highly recommended.

Travel

Be adaptable to business trips as required per business need; requires valid driver’s license in applicable countries.

Benefits

• Market competitive compensation package including performance‑based annual bonus scheme.
• Company shares.
• In‑house and external learning and development opportunities.
• Fantastic benefits program.

BeOne 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