[Remote] Associate Clinical Research Manager

Note: The job is a remote job and is open to candidates in USA. BeOne is hiring an Associate Clinical Research Manager to oversee clinical monitoring activities and CRA team performance across clinical trials. The role manages and develops a CRA team while ensuring quality, regulatory compliance, effective resource allocation, and study/site milestone delivery.

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
• 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

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
• Excellent interpersonal skills, strong organizational and effective written and verbal communication skills
• Bachelor's degree or higher in a scientific or healthcare discipline
• Previous experience as a CRA preferred
• Experience in Oncology is highly recommended
• Advanced degrees preferred

Benefits

• Remote work (US).
• 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 are eligible for discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan.
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Company Overview