Senior Manager, Clinical Operations Programs

LivaNova

2d•$160,000 - $190,000

About The Position

The Senior Manager, Clinical Operations Programs provides global clinical project management direction, prioritizes work, and ensures study objectives are delivered on time and within budget. The role leads a clinical operations team managing multiple studies that support business strategies and collaborates with study managers, support teams, and monitors to ensure high-quality study conduct. As a cross-functional team member, this role contributes to development programs in partnership with Clinical Science, provides study status updates, and responds to questions from Marketing, Regulatory, R&D, Market Access, Medical Affairs, PMO, and other groups. The role supports the Clinical Operations Director in achieving study goals, oversees program- and study-level outsourcing, and takes corrective action to resolve issues. It also drives continuous improvement and leads initiatives to enhance efficiency, transparency, quality, and compliance across clinical programs and departmental workflows. This is a build-and-scale leadership role. It manages cross-functional clinical project teams and global, multicenter studies, and contributes to clinical strategy, product development, long-term evidence-generation planning, and informed business decisions. The position includes mentoring and training project managers and staff in clinical practice, project management methods, tools, and procedures. Regular business travel of 35% or more is required.

Requirements

At least 8 years of clinical project or program management experience in a medical device environment, with demonstrated consistent professional advancement.
Strong project management skills.
Ability to translate strategic plans into prioritized product, development, or operational business objectives.
Strong written, verbal, and interpersonal communication skills; a writing sample is required from top candidates.
Ability to troubleshoot and make appropriate decisions under pressure, including handling multiple meetings at once.
Exceptional organizational skills.
High aptitude with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
Experience in a fast-paced, complex, dynamic, multicultural business environment.
Ability to build and maintain effective relationships with internal and external contacts.
Ability to work independently and in a group environment.
Fluent in English.
Bachelor’s degree in a scientific field or equivalent work experience.
Willingness to travel regularly for business, 35% or more of the time.

Nice To Haves

An additional European language is an asset.

Responsibilities

Provide overall clinical project management direction and prioritize work to deliver study objectives on time and within budget globally.
Lead multiple studies and manage cross-functional clinical project teams, including clinical project managers, associate project managers, and clinical trial assistants.
Work with study managers, support teams, and monitors to ensure high-quality studies.
Assess the assigned study portfolio within 30 days, identify critical action items, and develop and implement plans to meet company and department needs.
Understand clinical and regulatory program needs and coordinate with Clinical Science, the medical community, internal and external stakeholders, and the Clinical Operations Director to address them.
Identify study and program risks, develop mitigation strategies, resolve issues, and make necessary adjustments.
Set study activity priorities with Operations, Monitoring, and Data Management teams.
Collaborate with Regulatory, Medical Affairs, Clinical Operations, and other teams to support consistent, effective clinical program execution.
Maintain close communication with global stakeholders and communicate program updates and results to internal and external audiences.
Manage delivery of multicenter global clinical studies to meet inclusion-rate, timeline, and budget requirements across multiple studies.
Support the Clinical Operations Director in achieving study goals and oversee program- and study-level outsourcing.
Drive continuous process improvement by identifying operational gaps and implementing optimized solutions with stakeholders.
Lead strategic initiatives to improve efficiency, transparency, quality, and compliance across clinical programs and departmental workflows.
Contribute scientific rigor and critical thinking to the design and review of clinical study protocols.
Help develop and issue corporate-wide dashboards for major initiatives.
Provide expert input at Scientific & Technology Committee (STC) meetings and contribute to clinical strategy and study-related decisions.
Provide clinical insights to Product Development teams so clinical considerations are integrated into product strategy, innovation planning, and lifecycle management.
Support long-term clinical strategies and prioritization of studies, publications, and evidence-generation needs.
Mentor, train, and assist project managers and staff in clinical practice, protocol development, project management principles, methods, tools, techniques, and procedures.
Contribute to business cases that support informed strategic decisions.
Explain complex issues clearly and concisely and make appropriate decisions under pressure.
Travel regularly for business, 35% or more of the time.