Clinical Monitoring Associate Director (remote

Clinical Monitoring Associate Director

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 resourcing, 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:

• 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
• Manages and provides direction to CRAs and Lead CRAs, encouraging engagement, innovation and open communication while supporting Vertex and Global Clinical Operations goals
• Reviews visit reports and metrics to evaluate for compliance and trends, escalating issues and involvement in the development of corrective and preventative actions
• 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

Pay Range $156,000 - $234,000 USD annually

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.

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, 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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a…