Clinical Trial Manager

About This Role:

The Clinical Trial Manager will be integral to the planning, coordination, and execution of clinical trials for Class III medical devices, ensuring they are conducted in compliance with regulatory and quality standards. This position will be part of the Implantable Device Unit team, working closely with cross-functional partners, study sites, and external vendors to support effective trial operations. This role is crucial for tracking study progress, identifying operational risks, and contributing to the resolution of issues affecting timelines and data quality. The Clinical Trial Manager will support trial documentation, vendor oversight, and site management processes, playing a key role in delivering successful clinical trials under the leadership of the Director, Device Clinical. This position offers an opportunity to impact on the overall business by ensuring the safety and efficacy of class III medical devices that enhance patient care.

Responsibilities:

• Manage day-to-day execution and coordination of clinical trials for Class III medical devices.
• Track study activities, timelines, deliverables, and operational issues in partnership with cross-functional team members.
• Coordinate with study sites, CROs, and external vendors supporting class III medical device trials to ensure protocol-required activities are performed according to timelines and quality expectations.
• Monitor study progress and operational metrics for class III medical device trials, identifying risks and issues that may affect timelines and data quality.
• Support vendor oversight and site management for class III medical device clinical trials by reviewing performance and operational quality concerns.
• Collaborate with internal stakeholders such as Safety, Regulatory, Quality, and Data Management teams.
• Assist with documentation, vendor oversight activities, and site management processes.
• Facilitate communication among internal team members, CROs, and sites to maintain study continuity.
• Support regulatory submissions, protocol amendments, and safety reporting workflows.
• Organize and track class III medical device clinical trial follow-up activities like action item logs and issue trackers.

Qualifications and Experience:

• Clinical trial professional with class III medical device expertise who thrives in a dynamic environment where attention to detail and organizational skills are paramount.
• Have a passion for ensuring the success and safety of class III medical device clinical trials, with the ability to navigate complex issues and coordinate multiple stakeholders effectively.
• Proactive nature and excellent communication skills help you manage competing priorities and tight timelines with grace and efficiency.
• Committed to fostering collaboration and maintaining high standards of quality and compliance in every aspect of trial management.

Required Skills:

• Bachelor’s degree; advanced degree is preferred.
• At least 5 years of experience in clinical research or clinical operations.
• Experience supporting clinical trials for Class III implantable medical devices.
• Strong organizational and communication skills.
• Ability to track study progress and identify operational risks.
• Knowledge of regulatory and quality standards in clinical trials.

• Experience with vendor oversight and site management.
• Familiarity with regulatory submissions and protocol amendments.
• Expertise in safety reporting workflows and managing study changes.