Clinical Operations Manager

Change peoples lives and love what you do! Cochlear is the most recognized brand in hearing health care.

Clinical Operations Manager

Position Spotlight:

• 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 applicable national/international regulatory standards

• Hybrid work model of 3 days in office reporting to our North American headquarters in Lone Tree CO

• Willing to travel up to 20% regionally and internationally

• Relocation assistance is not available for this position

About the role

Change peoples lives and love what you do at Cochlearthe most recognized brand in hearing health carehelping people hear and be heard around the world while being part of one of Denver Business Journals 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 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.

Key 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 teams 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.

Key Requirements

To add value to Cochlear in this role youll be able to meet and demonstrate the following knowledge skills and abilities in your application and at interview:

• Bachelors 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.

Total Rewards

In addition to the opportunity to develop your knowledge and grow professionally we offer competitive wages and benefits.

• Pay Range in the United States: $135000 $145000 based upon experience as well as an annual bonus opportunity of 15% of base salary. Exact compensation may vary based on skills experience and location.

• Benefit package includes medical dental vision life and disability insurance as well as 401(K) matching with immediate vesting Paid Time Off tuition reimbursement maternity and paternity leave Employee Stock Purchase Plan and pet insurance.

Who are we

Human needs have always been our inspiration ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind thinking about their needs.

For this reason our products services and support will continue to evolve and improve. We are by our customers side through the entire hearing journey so they can experience a life full of hearing. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to peoples lives and working in an organization where they can be part of bringing the mission to life each day.

Physical & Mental Demands

The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery communicate orally and in writing with others internal or external to the organization utilize problem solving/critical thinking skills to discern and convey information. May be asked to occasionally transport/move up to 30 pounds depending on the position. Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension critical thinking communication problem solving organization reasoning relating to others and discernment of items such as product specifications procedures and processes to customers (whether internal or external). Influence organization/classification of information and planning are also required.

The work environment is a home/office clinical or hospital environment. This is representative of the environment an individual may encounter while performing the essential functions of this job.

Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at to learn more.

Cochlear Americas is an Equal Opportunity Employer. We will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application please contact us via web or phone at .

Application deadline: May 31 2026