Clinical Operations Manager

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as their Manager, Clinical Operations. Reporting to the Director, Clinical Operations, you will play a pivotal role in ensuring the excellence of clinical trial planning, execution, and data collection. This position demands expertise in various aspects of clinical study conduct, including site selection, study start-up, and close-out. You will be responsible for managing vendor relationships, overseeing patient enrollment, and ensuring the accuracy of data collection. The ideal candidate is a highly motivated, results-oriented individual with a strong background in clinical operations and a proven ability to lead and mentor team members. This role offers the opportunity to contribute significantly to the advancement of oncology drug development within a collaborative and supportive environment.

Requirements

• Have at least 3 years of Clinical Operations experience
• Have a Bachelor’s degree or higher in a scientific or healthcare discipline
• Possess knowledge of ICH-GCP guidelines
• Have relevant experience managing early through late Phase clinical trials

Responsibilities

• Lead aspects of clinical studies and perform vendor management working under the guidance and direction of the Clinical Study and Program Lead
• Be 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 over-sight 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 con-sent 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

Preferred Qualifications

• Have 3-5 years of progressive experience in clinical research or clinical operations or related experience
• Possess knowledge of oncology clinical trials
• Have experience in managing international clinical trials
• Demonstrate cross-functional leadership and communication fostering team spirit and team motivation
• Have the capability to challenge status-quo using risk management approach