Hybrid Manager, Clinical Operations

at Nuvalent, Inc.

• Job title: Manager, Clinical Operations
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $125,000 - $145,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Cambridge, United States

About the role

• Manager, Clinical Operations at Nuvalent overseeing clinical trial planning, execution, and data collection according to regulatory guidelines. Responsible for various aspects of clinical study conduct and ensuring high-quality results.

Responsibilities

• Manage multiple aspects of clinical studies working under the guidance and direction of the Clinical Program Lead.
• Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget.
• Perform oversight of CRO and auxiliary vendors; identify risks and broker solutions.
• Provide support and oversight managing the creation, maintenance and close out of TMF activities.
• Ensure appropriate escalation of enrollment, site activation and data collection milestones.
• Support the clinical team to ensure the completeness of clinical protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are adhered to.
• Support database lock by ensuring appropriate oversight of sites and by participating in data review/reconciliation efforts.
• Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites.
• Establish and maintain effective communication and collaboration with functional area peers to meet study/program objectives and support goals.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 3+ years relevant experience in clinical operations within the biotech, pharmaceutical or CRO industry.
• Extensive knowledge of ICH-GCP guidelines.
• Relevant experience in early through late Phase clinical trials.
• Knowledge of oncology clinical trials preferred.
• Demonstrated cross-functional leadership fostering team spirit and team motivation.
• Capability to challenge status-quo using risk management approach.

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off (including a summer and winter company shutdown)
• competitive total rewards package