BeiGene · 2 hours ago
Clinical Research Manager
United States
Full-time
Remote
Senior Level
$119K/yr - $159K/yr
5+ years expBeOne Medicines USA is a rapidly growing company focused on fighting cancer through innovative clinical research. The Clinical Research Manager is responsible for overseeing clinical monitoring activities and the performance of the CRA team, ensuring compliance with regulations and maintaining quality across clinical trials.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
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 financially best local practices
Identify opportunities for cost-saving and efficiency while maintaining quality and compliance standards
Performs recruiting and hiring activities, along with onboarding new team members to ensure alignment with team objectives and culture
Assign tasks based on individual strengths and team objectives, ensuring optimal productivity
Support team members by providing necessary resources to help them effectively perform their roles
Encourage open communication and collaboration within the team and with other functions, including a point of contact for issue escalation and feedback where required
Conduct regular performance evaluations and provide constructive feedback to promote continuous improvement
Lead and mentor team members, fostering an environment of growth and development
Address any personnel issues promptly and fairly to maintain a positive work environment
Support team members in identifying and pursuing professional development opportunities
Qualification
Required
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
Demonstrated team leadership experience
Bachelor's degree or higher in a scientific or healthcare discipline
Preferred
Minimum 2 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
Experience in Oncology is highly recommended
Advanced degrees preferred
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
0-1 employees
H1B Sponsorship
BeiGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (32)
2023 (39)
2022 (40)
2021 (28)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgen
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Leadership Team
Dirk Weber
Executive Director Medical Affairs (Europe)
Lai Wang
Global Head of Research and Development
Recent News
2026-01-07
Company data provided by crunchbase