Manager - Clinical Operations

September 19

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Nuvalent, Inc.

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Description

• Lead aspects of clinical studies and perform vendor management working under the guidance and direction of the Clinical Study and Program Lead. • Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget. • Manage the review and approval of vendor and site contracts and budgets. Provide support and oversight managing the creation, maintenance and close out of TMF activities. • Ensure appropriate oversight of patient enrollment, site activation and data collection milestones. • Support 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 being adhered to. • Support timeline and efficient database lock by ensuring monitoring plans are in place and by participating in data review/reconciliation efforts. • Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites. • Identify risks and broker solutions to facilitate clinical studies. Establish and maintain effective communication and collaboration with functional area peers and clinical trial sites to meet program objectives and support goals. • Mentor junior team members to support development by delegating responsibilities, overseeing, and supporting clinical studies. • 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 3-5 years of progressive experience in clinical research or clinical operations or related experience. • Knowledge of ICH-GCP guidelines. • Relevant experience managing early through late Phase clinical trials. • Knowledge of oncology clinical trials preferred. • Experience in managing international clinical trials preferred. • Cross-functional leadership and communication fostering team spirit and team motivation. • Capability to challenge status-quo using risk management approach.