Senior Manager, Clinical Operations

Nuvalent - Cambridge, MA

Full-time - Mid Level

Remote - Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The Senior Manager, Clinical Operations at Nuvalent is responsible for ensuring excellence in clinical trial planning, execution, and data collection in compliance with regulatory guidelines. This role involves leading clinical studies, managing cross-functional teams, and collaborating with CROs and vendors to deliver high-quality clinical trial results. The ideal candidate will have a proven track record in executing complex clinical trials within the biotech or pharmaceutical industry.

Responsibilities

• Lead and manage one or multiple clinical studies, demonstrating thorough knowledge of clinical operations project management.
• Evaluate, select, and ensure appropriate oversight of CROs and other external vendors.
• Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and goals.
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives.
• Identify risks and propose solutions to facilitate clinical studies.
• Develop and manage study-level budgets, overseeing contract reviews and approvals, and managing budget forecasting and accruals in collaboration with finance.
• Oversee and manage the creation, maintenance, QC, and close-out of TMF activities.
• Ensure appropriate oversight of enrollment, site activation, and data collection milestones.
• Contribute to the completeness of study documents including study protocol, investigator brochure, informed consent forms, clinical study reports, and case report forms.
• Collaborate with the Clinical Data Manager to ensure timely and efficient database lock and participate in data review and reconciliation efforts.
• Mentor junior team members by delegating study-related responsibilities and supporting their development plans.
• Lead or co-lead department initiatives to support an expanding organization.

Requirements

• At least 5 - 7 years of Clinical Operations experience.
• Bachelor's degree or higher in a scientific or healthcare discipline preferred with 7+ years relevant experience within the biotech, pharmaceutical, or CRO industry.
• Extensive knowledge of ICH-GCP guidelines.
• Relevant experience managing early through late Phase clinical trials.
• Experience in managing oncology global Phase 3 clinical trials.
• Demonstrated cross-functional leadership fostering team spirit and motivation.
• Capability to challenge the status quo using a risk management approach.
• Ability to thrive in a remote/virtual environment.