Manager, Clinical Operations

The Role:

Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands.

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%).

 Competencies:

• Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
• Excellent problem solving, communication and organization skills.
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization.
• Ability to strategically plan, organize and manage multiple projects simultaneously. 

 Qualifications:

• 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.

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.