Clinical Monitoring Associate Director

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:

Disclosure Statement:

Flex Designation:

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