百济神州
(Associate) Director, Site Management
岗位职责
of the Job: •Team Resource Allocation & Performance •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. •Expense Review and Management - 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. •People Management and Mentoring - Serve as the second-line manager, providing oversight, strategic direction, and support to ensure team alignment with organizational objectives. - Mentor and guide junior Clinical Research Managers (CRMs) and first line managers, fostering their professional growth and development. - Facilitate learning opportunities and provide insights and feedback to help team members succeed in their roles. • Leadership of Taskforce and Initiatives - 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. - 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
任职要求
Fluent in written and verbal English • Minimum 10 years of industry experience in the pharmaceutical or CRO or relevant field • Minimum 5 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred • 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. • 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
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