Clinical Research Operations Manager

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!

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 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
• 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.

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.

Compensation

• 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.

Benefits

• Medical, dental, vision, life and disability insurance
• 401(K) matching with immediate vesting
• Paid Time Off
• Tuition reimbursement
• Maternity and paternity leave
• Employee Stock Purchase Plan
• Pet insurance