Clinical Ops Manager (Feasibility)

Novartis - East Hanover, NJ

Full-time - Mid Level

Remote - East Hanover, NJ

Chemical Manufacturing

About the position

The Clinical Operations Program Manager (COPM) at Novartis will provide operational support for clinical development programs and trials, focusing on early viability, feasibility, allocation, and site selection activities. This role is crucial for ensuring the successful execution of clinical trials by conducting feasibility assessments, developing strategic plans, and managing key deliverables throughout the process.

Responsibilities

• Conduct end-to-end feasibility process starting from early viability assessments and trial feasibilities.
• Develop strategic allocation, site selection, and recruitment plans for assigned programs and trials.
• Prepare and coordinate briefing information, training resources, and other materials.
• Provide project planning support and manage key deliverables.
• Lead aspects of feasibility activities, including survey consolidation and data insights review.
• Coordinate and manage information gathering questionnaires for feasibility at trial level.
• Ensure feedback from feasibility assessments is addressed and aligned with country feasibility teams.
• Elaborate scenarios for geographic country footprint and proposed sites for clinical trial participation.
• Evaluate prospective sites on their operational and medical capability to conduct studies and provide thorough analysis of feasibility outcomes.
• Contribute to the development of risk management strategies for clinical trials.

Requirements

• Bachelor's degree in life science/healthcare.
• 3+ years of pharmaceutical clinical drug development experience.
• 1+ year of experience in planning/execution of global clinical trials.
• Strong understanding of clinical drug development, particularly clinical trial design and execution.
• Demonstrated experience in feasibility for global clinical trials.
• Proven success in identifying and resolving risks, with experience in strategic scenario planning.
• Ability to understand and communicate analytical data insights.

Benefits

• Restricted Stock Units (RSU)
• Paid time off
• Parental leave
• 401(k) eligibility
• Vacation and sick time benefits