Note: The job is a remote job and is open to candidates in USA. BeOne is a life sciences company focused on developing medicines and fighting cancer. The Associate Clinical Research Manager oversees clinical monitoring activities and CRA team performance, ensuring compliance with ICH-GCP, local regulations, and company SOPs. The role also manages team resources, supports study delivery and audits, and provides recruitment, performance management, mentoring, and development support.
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
- 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 acting as 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
Skills
- Proficient in Microsoft Word, Excel, PowerPoint and Outlook
- 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
- Be adaptable to business trips as required per business need; require valid driver's license in applicable countries
- Bachelor's degree or higher in a scientific or healthcare discipline, and advanced degrees preferred
- Experience in Oncology is highly recommended
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan.
- Commercial roles are eligible to participate in an incentive compensation plan.
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards.
- All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan.
- Medical benefits
- Dental benefits
- Vision benefits
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Company Overview