Clinical Operations Manager

1w1 week ago

Cochlear

Lone Tree, US · Full-time · $135,000 – $145,000

About this role

Change people’s lives and love what you do at Cochlear, the most recognized brand in hearing health care. This people leadership role oversees a high-performing team of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs). Ensure successful delivery of clinical research projects aligned to business priorities.

The Clinical Operations Manager functions as a Senior Clinical Project Manager, directly executing and overseeing pre- and post-market clinical trials. Deliver trials on time, within budget, and in compliance with global regulations including ISO 14155 and ICH-GCP. Partner cross-functionally on study planning, site execution, regulatory submissions, and vendor management.

Supervise day-to-day clinical operations for Class II and Class III medical device trials in a hybrid model of 3 days in office. Foster a culture of quality, collaboration, and continuous improvement across the team. Report to North American headquarters in Lone Tree, CO, with up to 20% regional and international travel.

Join one of Denver Business Journal’s 2026 Best Places to Work honorees in Denver. Build and develop your team through mentorship, career development, and performance feedback. Drive inspection readiness and inspection readiness while advancing implantable hearing devices globally.

Requirements

Bachelor’s degree in health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or related discipline
5+ years clinical investigation experience from industry
Experience leading clinical investigations and monitoring in the medical device/pharmaceutical industry
Passion for leadership in clinical operations
Knowledge of ISO 14155 and ICH-GCP standards
Ability to manage clinical trials on time, within budget, and in compliance

Responsibilities

Oversee clinical operations team in Class II and Class III medical device clinical trials
Ensure the compliant execution of all clinical trial activities in accordance with national/international regulatory standards
Supervise and develop a clinical operations team of CRAs and CTAs, providing mentorship and performance feedback
Fulfil the role of Senior Clinical Project Manager in Cochlear Sponsored clinical investigations
Ensure sponsored clinical investigations are implemented per ISO 14155, ICH-GCP, local regulations, and Cochlear SOPs
Provide clear, accurate and timely communication on progress, key risks, and financial performance to stakeholders
Assist in the preparation and delivery of information for regulatory submissions and audits