Note: The job is a remote job and is open to candidates in USA. BeOne Medicines USA, Inc. is a rapidly growing company focused on fighting cancer. The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance, ensuring compliance with regulations and maintaining quality across clinical trials.
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
- Provide mentorship and guidance to junior Clinical Research Managers (CRMs), supporting their professional growth and development if required
- Facilitate learning opportunities and provide valuable insights and feedback to help upskill and promote consistency within the wider team
- Lead and contribute to strategic initiatives and task forces aimed at improving clinical operations processes and outcomes, driving projects from inception to completion in alignment with organizational goals and in collaboration with cross-functional teams
- Perform 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
Skills
- Fluent in written and verbal English
- Minimum 7 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
- 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
- Proficient in Microsoft Word, Excel, PowerPoint and Outlook
- Minimum 4 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred
- Understanding of all aspects of monitoring and trial execution, with previous experience as a CRA preferred
- Experience in Oncology is highly recommended
- Advanced degrees preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan, and 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 and to voluntarily participate in the Employee Stock Purchase Plan.
- The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Company Overview
Company H1B Sponsorship