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Nuvalent is a biotechnology research company developing precisely targeted therapies for patients with cancer. To do so, Nuvalent employs professionals across a
Senior Manager, Clinical Operations
Location
Massachusetts
Posted
117 days ago
Salary
$145K - $175K / year
Seniority
Senior
Job Description
Senior Manager, Clinical Operations
Nuvalent
• Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. Collaborate with cross-functional clinical study team to support clinical study delivery. • Evaluates, and ensures 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. • Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to 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 and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms. • Collaborate with Data Management to ensure timely and efficient database lock. Participate in data review and reconciliation efforts. • Lead or co-lead department initiatives to support an expanding organization.
Job 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 (including a summer and winter company shutdown)
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