Clinical Monitoring Associate Director at Vertex Pharmaceuticals | Torre
Clinical Monitoring Associate Director
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Vertex Pharmaceuticals

Clinical Monitoring Associate Director

Vertex Pharmaceuticals
Emma
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Full-time

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Remote (for United States residents)
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Emma of Torre.ai
 14 days ago

Responsibilities

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 ResponsibilitiesManages and provides direction to CRAs and Lead CRAs, encouraging engagement, innovation and open communication while supporting Vertex and Global Clinical Operations goalsConducts Quality Oversight Visits as required to assess relationship and effectiveness of CRAs work while on siteReviews visit reports and metrics to evaluate for compliance and trends, escalating issues and involvement in the development of corrective and preventative actionsAssists 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 workloadContributes to developing and updating best practices and processes and provides input on discussions around quality by design and operational deliveryDevelop 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 regulationsLeads 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 timesRepresents 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 MonitoringKnowledge and SkillsFundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCPExcellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environmentStrong interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirementsAbility to successfully coach and mentor other team membersAbility to successfully execute programs in a fast-paced environment managing multiple prioritiesAbility to travel up to 30% of the timeEducation and ExperienceBachelor's degree or equivalent relevant experience requiredTypically 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 experienceAt 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.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 DesignationRemote-EligibleIn this Remote-Eligible role, you can choose to be designated as:Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or selectHybrid: work remotely up to two days per week; or selectOn-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.Company InformationVertex is a global biotechnology company that invests in scientific innovation.
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