临床监测助理总监
Clinical Monitoring Associate Director
**职位描述**
**岗位概述：**
临床监查主任负责确保临床监查职能内所有所需工作的按时监查和高质量交付。负责临床监查培训和质量监督，以确保符合良好临床实践和法规要求。该职位还将与全球临床运营（GCO）团队的其他职能密切合作，报告临床机构管理、关键研究特定和项目更新，以及临床监查流程开发。
**主要职责和任务：**
管理并指导CRAs和高级CRAs，鼓励参与、创新和开放沟通，同时支持Vertex和全球临床运营目标
根据需要进行质量监督访问，评估CRAs在机构现场的工作关系和有效性
审查访问报告和指标，评估合规性和趋势，上报问题并参与制定纠正和预防措施
协助资源分配预测/规划和机构分配，贯穿临床研究的整个生命周期，确保实现适当的临床机构表现和监督；可能监控和评估临床研究助理（CRA）和高级CRA的工作量，并与临床监查管理团队联络，确保资源的适当分配和最优利用及工作量
参与制定和更新最佳实践和流程，并就质量设计和运营交付的讨论提供意见
开发内容并进行临床监查流程的培训，用于新员工入职和部门持续培训，确保部门符合Vertex程序、ICH-GCP和当地法规
领导CRAs按时高质量地进行临床监查，确保CRAs始终使机构处于监管机构检查和审计的准备状态
根据需要代表临床监查进行审计/检查，主导CAPA计划和调查的开发，确保检查发现得到整改，并在临床监查中实施相关流程
**知识和技能：**
熟悉临床研究，精通临床试验各阶段；全面了解ICH-GCP；优秀的远程团队管理能力
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**Job Description**
**General Summary:**
The Clinical Monitoring Associate Director is responsible for ensuring on-time monitoring and quality delivery of all required work assignments within the Clinical Monitoring function. Responsible for clinical monitoring training and quality oversight to ensure compliance with Good Clinical Practice and regulations. This position will also work closely with other functions in the Global Clinical Operations (GCO) team to report on clinical site management, important study specific and program updates, as well as process development for clinical monitoring.
**Key Duties and Responsibilities:**
Manages and provides direction to CRAs and Lead CRAs, encouraging engagement, innovation and open communication while supporting Vertex and Global Clinical Operations goals
Conducts Quality Oversight Visits as required to assess relationship and effectiveness of CRAs work while on site
Reviews visit reports and metrics to evaluate for compliance and trends, escalating issues and involvement in the development of corrective and preventative actions
Assists in resource allocation projections/forecasting and site assignments throughout the clinical study(ies) lifecycle, ensuring proper clinical site performance and oversight is achieved; may monitor and evaluate Clinical Research Associate (CRA) and Lead CRA workloads and liaise with the Clinical Monitoring management team to ensure appropriate allocation of resources and optimal utilization and workload
Contributes to developing and updating best practices and processes and provides input on discussions around quality by design and operational delivery
Develop content and deliver training on Clinical Monitoring processes for new hire on-boarding and ongoing department training, ensuring the department is compliant with Vertex procedures, ICH-GCP and local regulations
Leads the on-time and high-quality clinical monitoring by CRAs, ensuring CRAs maintain their sites inspection ready for health authority inspections and audits at all times
Represents Clinical Monitoring for audits/inspections as needed, leading the development of CAPA plans and investigations, ensuring inspection findings are remediated and processes are implemented within Clinical Monitoring
**Knowledge and Skills:**
Fundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCP Excellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environment
Strong interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements
Ability to successfully coach and mentor other team members
Ability to successfully execute programs in a fast-paced environment managing multiple priorities
Ability to travel up to 30% of the time
**Education and Experience:**
Bachelor's degree or equivalent relevant experience required
Typically requires 8 years of experience, including extensive Clinical Research experience with strong experience in clinical site monitoring, including a Lead CRA role, or experience working as a Project Manager, CRA Manager or equivalent, or the equivalent combination of education and experience
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
**Pay Range:**
$157,200 - $235,800
**Disclosure Statement:**
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
**Flex Designation:**
Remote-Eligible
**Flex Eligibility Status:**
In this Remote-Eligible role, you can choose to be designated as:
1. **Remote**: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; **or select**
2. **Hybrid**: work remotely up to two days per week; **or select**
3. **On-Site**: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Remote
**Company Information**
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com