Job Information
BeOne Medicines Clinical Research Manager in San Mateo, California
General Description:
The 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:
• Team Resource Allocation & Performance
- 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.
• Quality and Compliance
- Review monitoring quality and resolve issues to ensure compliance with
regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices.
Effective September 01, 2025
- 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.
• Expense Review and Management
- Review and approve expenses related to CRA activities to ensure alignment with
applicable policies and financially best local practices.
- Identify opportunities for cost-saving and efficiency while maintaining quality and
compliance standards.
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: Assign tasks based on individual strengths and team objectives,
ensuring optimal productivity.
• Support and Resource Provision: Support team members by providing necessary
resources to help them effectively perform their roles.
• Communication and Collaboration: Encourage open communication and
collaboration within the team and with other functions, including a point of contact for
issue escalation and feedback where required.
• Performance Evaluation: Conduct regular performance evaluations and provide
constructive feedback to promote continuous improvement.
• Mentoring and Development: Lead and mentor team members, fostering an
environment of growth and development.
• Issue Resolution: Address any personnel issues promptly and fairly to maintain a
positive work environment.
• Career Development Support: Support team members in identifying and pursuing
professional development opportunities.
Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint and Outlook
Other Qualifications:
• Fluent in written and verbal English
• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field
• Minimum 2 years of People management or project management experience in
progressive clinical research within the biotech, pharmaceutical sector, CRO industry or
relevant field is preferred
Effective September 01, 2025
• 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; require valid driver’s
license in applicable countries
Education Required:
Bachelor’s degree or higher in a scientific or
healthcare discipline, and advanced degrees
preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.