Associate Clinical Research Manager
BeiGene
Summary
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.
Job description
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.
- 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.
Requirements
- 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
- Proficient in Microsoft Word, Excel, PowerPoint and Outlook
- Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred
- Valid driver’s license in applicable countries
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual Bonus Plan
- Discretionary Equity Awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.