Associate Clinical Research Manager

BeiGene

1d • $105,800 - $140,800

About The Position

The Associate Clinical Research Manager oversees clinical monitoring activities and CRA team performance to ensure compliance with ICH-GCP, local regulations, and company SOPs, while maintaining quality across clinical trials. As a line manager, the role leads a team toward organizational goals and high performance by providing guidance, support, and development opportunities and promoting a positive team culture.

The role allocates CRA resources, assesses workload and performance, ensures CRAs have the knowledge and skills needed for high-quality monitoring, and addresses performance and quality indicators. It supports study and site milestones, assesses CRA competency through assessment and accompanied visits, contributes to process optimization, manages risk escalation and resolution, and supports audits, inspections, and Site Compliance Visits.

The position includes recruiting, onboarding, task assignment, resource provision, communication and collaboration, performance evaluations, mentoring, personnel issue resolution, and career-development support. It requires adaptability for business travel and a valid driver’s license in applicable countries.

Requirements

• Minimum 5 years of industry experience in the pharmaceutical, CRO, or a relevant field.
• Thorough understanding of the drug development process, including expert knowledge of ICH-GCP and health authority requirements.
• Understanding of monitoring and trial execution; previous CRA experience is preferred.
• Excellent interpersonal skills and strong organizational, written communication, and verbal communication skills.
• Fluent written and verbal English.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Bachelor’s degree or higher in a scientific or healthcare discipline.
• Adaptability for business trips as required; valid driver’s license in applicable countries.

Nice To Haves

• Previous experience as a CRA.
• Experience in Oncology is highly recommended.
• Advanced degree preferred.

Responsibilities

• Allocate CRA resources and conduct ongoing resource assessments to balance workloads and meet study deliverables.
• Ensure CRAs have the monitoring knowledge and skills required to perform their activities to a high standard.
• Manage and address CRA performance and quality indicators in accordance with ICH-GCP, SOPs, and local regulations.
• Strengthen site relationships to improve performance and uphold the company’s trial delivery reputation.
• Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP, and Good Clinical Practices.
• Support study and site milestone delivery in collaboration with cross-functional teams.
• Execute assessment and accompanied visits as needed to assess CRA monitoring competency, identify issues, and develop resolution strategies.
• Contribute to process optimization and manage risk escalation and resolution.
• Support site audits, inspections, and Site Compliance Visits, and ensure corrective action and follow-up for identified issues.
• Recruit and hire team members and onboard them in alignment with team objectives and culture.
• Assign tasks according to individual strengths and team objectives.
• Provide team members with resources and support to perform their roles effectively.
• Encourage communication and collaboration within the team and with other functions, serving as a point of contact for escalation and feedback where required.
• Conduct regular performance evaluations and provide constructive feedback.
• Lead and mentor team members and support their professional development.
• Address personnel issues promptly and fairly.
• Support team members in identifying and pursuing professional development opportunities.
• Travel on business as required.

Benefits

• Annual bonus plan eligibility for non-commercial roles; incentive compensation plan eligibility for commercial roles.
• Opportunity for all employees to own BeOne Medicines Ltd. shares through discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
• Medical, dental, and vision coverage.
• 401(k).
• FSA/HSA.
• Life insurance.
• Paid time off.
• Wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager