Senior Manager, Clinical Operations Programs

General Responsibilities

• Applies critical thinking and scientific rigor in the design and review of clinical study protocols, ensuring methodological robustness and strategic alignment.
• Manage multiple cross-functional clinical project teams in support of clinical portfolio made up of clinical project managers, associate project managers and clinical trial assistants.
• Ensure that high quality clinical studies are conducted following the highest ethical, regulatory and GCP standards.
• Assess the currently assigned study portfolio within 30 days and identify critical action items and develop/implement appropriate plans to meet company and department needs.
• Understand the Clinical and Regulatory needs of the program and help ensure the needs are met with the new/existing studies to be conducted.
• Proactively identify project/study/program risks and develop mitigation strategies by addressing issues and making necessary adjustments.
• Set study activity priorities together with the Operations, Monitoring and Data Management teams.
• Collaborates cross-functionally with Regulatory, Medical Affairs, Clinical Operations, and other key teams to ensure consistency and excellence in clinical program execution.
• Ensure close communication with all global stakeholders.
• Managing the delivery of multi-center global clinical studies to meet the needs and required inclusion rate, timelines and budget set for multiple studies.
• Responsible for communicating program updates and results to various internal and external stakeholders.
• Assist in the development and issuance of corporate-wide dashboards for major initiatives.
• Provides expert input during STC (Scientific & Technology Committee) meetings, contributing to clinical strategy and supporting decision-making on study-related activities.
• Offers clinical insights to Product Development teams, ensuring that clinical considerations are integrated into product strategy, innovation planning, and lifecycle management.
• Supports development of long-term clinical strategies, enabling informed prioritization of studies, publications, and evidence-generation needs.
• Lead the general mentoring, training and assistance on protocol development and project management methodologies to improve the skills of project managers.
• Train and mentor staff in clinical practice, project management principles, methodologies, and procedures.

Skills and Experience

• Minimum 8 years clinical project/program management experience in a medical device environment with demonstrated consistent professional advancement.
• Strong project management skills.
• Ability to convert strategic plans to prioritized product, development and/or operational business objectives.
• Strong communication skills (written, verbal, interpersonal). A writing sample will be required from top candidates.
• Ability to troubleshoot and make appropriate decisions under pressure as well as handle multiple meetings at one time.
• Exceptional organizational skills.
• High aptitude for MS Office computer applications (Outlook, Word, Excel, PowerPoint).
• Experience working in a fast-paced, complex, dynamic, multi-cultural business environment.
• Ability to build and maintain effective relationships with internal and external contacts.
• Ability to work both independently and in a group environment.
• Fluent in English. An additional European language is an asset.

Education

Bachelor's degree in scientific field or equivalent working experience.

Travel Requirements

This position requires regular business travel of 35% or more of the time.