Senior Manager, Clinical Operations

🕒 April 6

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $145k - $175k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Nuvalent, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.

📋 Description

• Reporting to the Associate Director, Clinical Operations, ensure excellence in clinical trial planning, execution, and data collection according to regulatory guidelines. • Work on a clinical study with responsibilities including site selection, contract negotiation, budget management, study start-up, conduct and close-out. • Collaborate with cross-functional study team and demonstrate excellent management of and partnership with CROs and vendors. • Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. • Evaluate and ensure appropriate oversight of CROs and other external vendors. • Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals. • Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals. • Identify risks and propose solutions to facilitate clinical studies. • Review and oversee the study-level budget(s) and demonstrate accountability for the management of the budgets. • Oversee and manage the creation, maintenance, QC and close out of TMF activities. • Ensure appropriate oversight of enrollment, site activation and data collection milestones.

🎯 Requirements

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

🏖️ Benefits

• medical, dental, and vision insurance • 401(k) retirement savings plan • generous paid time off • summer and winter company shutdown • comprehensive benefit package