Clinical Operations Manager

Cochlear•Lone Tree, CO

1d•Hybrid

About The Position

Change people’s lives and love what you do at Cochlear—the most recognized brand in hearing health care—helping people hear and be heard around the world, while being part of one of Denver Business Journal’s 2026 Best Places to Work honorees in Denver. If you have experience leading clinical investigations and monitoring in the medical device/pharmaceutical industry and a passion for leadership, this is a fantastic opportunity to join the Clinical Operations team at the global leader in implantable hearing devices! In this role, you will be based in our Americas head office in Lone Tree, CO. The Clinical Operations Manager is a people leadership role responsible for building, developing, and overseeing a high-performing team of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) while ensuring the successful delivery of clinical research projects aligned to business priorities. In addition to leading day-to-day clinical operations, this role also functions as a Senior Clinical Project Manager, directly executing and overseeing pre- and post-market clinical trials, ensuring they are delivered on time, within budget, and in compliance with global regulations including ISO 14155 and ICH-GCP. The position partners cross-functionally to drive study planning, site execution, regulatory submissions, vendor management, and inspection readiness, while fostering a culture of quality, collaboration, and continuous improvement across the clinical operations team.

Requirements

Bachelor’s degree in health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or related discipline.
5+ years clinical investigation experience from industry (medical device or pharma).
Significant experience conducting sponsored clinical investigations (medical device preferred), with solid understanding of applicable standards and guidelines ICH-GCP, ISO 14155:2020, and local regulations.
Demonstrated leadership capability through building and developing teams and/or executing successful clinical investigations and business initiatives involving cross functional teams.
Clinical investigation monitoring experience.
Advanced knowledge in using electronic data capture (EDC), Clinical Trial Management Systems (CTMS) and electronic trial master file (eTMF) systems, project planning and managing and maintaining budgets.
Ability to coordinate clinical research activities across multiple projects simultaneously.
Excellent organisational and problem-solving skills.
Excellent written and verbal communication.
Willing to travel up to 20% regionally and internationally, as required.

Responsibilities

Supervise and develop a clinical operations team, ensuring high-quality performance and retention.
Provide mentorship, career development opportunities, and performance feedback, fostering a culture of performance excellence and team collaboration.
Responsible for day-to-day team operations for CRAs and CTAs.
Ensure responsibilities are fulfilled according to applicable Cochlear Standard Operating Procedures (SOPs).
Fulfil the role of Senior Clinical Project Manager (CPM) in Cochlear Sponsored clinical investigations.
Ensure that sponsored clinical investigations are implemented and performed in accordance with ISO 14155 and ICH-GCP, local regulations, and Cochlear SOPs.
Provide clear, accurate and timely communication on the progress of the Clinical Operation team´s activities against objectives, key risks, and financial performance through the established periodic reporting processes to management and key stakeholders.
Assist in the preparation and delivery of information associated with submissions and dialogue with Regulatory Authorities to support product approvals and audits.