Clinical Research Operations Manager

Clinical Research Operations Manager (Internal title: 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 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.



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 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.
  

Key Requirements



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

• 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.
  

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: $135,000 - $145,000 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 people's 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 www.cochlear.us/careers 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 303-264-2549.



Application deadline: May 31, 2026