Associate Clinical Research Manager

BeOne Medicines; Emeryville (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

BeOne Medicines is seeking an Associate CRM to oversee clinical monitoring and lead the CRA team to achieve high performance. You will allocate CRA resources, ensure monitoring quality, and maintain compliance with ICH-GCP and SOPs while fostering a positive team culture.

The role requires at least 5 years in pharma or CRO, strong communication, and travel readiness. You will collaborate across functions to meet study milestones and support audits and inspections as needed.

Qualifications

• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field.
• Thorough understanding of the drug development process, including ICH-GCP and health authority requirements.
• Experience monitoring and trial execution; CRA experience preferred.
• Excellent interpersonal, organizational, and written and verbal communication skills.
• Fluent in written and verbal English.

Responsibilities

• Oversee CRA team performance and allocate resources for quality monitoring and study deliverables.
• Ensure CRA knowledge and skills meet required monitoring standards.
• Manage CRA performance, quality indicators, and regulatory compliance.
• Strengthen site relationships to uphold trial delivery reputation.
• Support site audits and inspections with corrective actions.

Skills

MS Office

Microsoft Word

Excel

PowerPoint

Outlook

Education

Bachelor’s degree in science/healthcare

Advanced degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

General Description

The Associate CRM 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.

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 acting as 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

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.

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.