Senior Clinical Operations Manager

• Application deadline: March 7, 2025

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 or remote work model depending on place of residence
• Able to travel up to 30%

About the role

Cochlear is helping people hear, and be heard, all over the world. Come be a part of our amazing mission and join the number one most trustworthy company in the healthcare industry as recognized by Newsweek in its 2024 rankings of the World's Most Trustworthy Companies! If you have experience in medical device clinical research, this is a fantastic opportunity to join the Clinical Affairs 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 offering a hybrid or remote work environment depending on place of residence with preference for Denver-based candidates. A remote employee must travel to the Lone Tree office for one week each month.

To be successful in this role, you'll oversee the clinical operations team in executing and managing Class II and Class III clinical trials in compliance with applicable SOPs, global and local regulations, including the Code of Federal Regulations (21 CFR), ISO 14155, and Good Clinical Practice (GCP). This role is pivotal in ensuring that clinical operations are conducted with the highest standards of quality and compliance. The ideal candidate will have experience in class II/III medical device clinical research, strong leadership capabilities, regulator inspection experience, and a passion for innovation in healthcare.

As the Senior Clinical Operations Manager, you will work in close collaboration with relevant internal and external key stakeholders to ensure high standards of clinical study execution that deliver clinical data to support the desired ethical and evidence-based claims. You will collaborate with cross functional teams such as Regulatory, Product Marketing, Health Economics and Quality and act as a Cochlear liaison with key industry personnel in the generation of clinical evidence that increases industry knowledge surrounding implantable hearing technology.

Key Responsibilities

• Team Leadership: 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.
• Resource Allocation: Ensure resourcing adequately supports the overarching clinical operation plans to achieve department goals and strategic imperatives. Ensure adherence to timeline and budget.
• Inspection Readiness: Ensure team members adhere to established protocols and operational plans and have appropriate oversight of assigned study sites. Participate in internal and external audits to ensure compliance with Good Clinical Practice guidelines and applicable regulatory requirements for Class II and Class III medical products.
• Continuous Improvement: Drive initiatives for continuous improvement and corrective action to maintain high standards of quality and integrity in clinical projects.

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 life sciences, nursing, or a related field.
• Minimum of 7 years of experience in clinical research, with at least 1 to 2 years in a managerial role. Experience in Class II or Class II medical device is preferred.
• Certification in clinical research (e.g., CCRP, CCRA) is preferred.
• Advanced knowledge in Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and ISO14155.
• Advanced knowledge in clinical research platforms such as clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file (eTMF).
• Proficient in supporting multi-center clinical research projects and clinical site monitoring activities.
• Experience with both internal and external audits to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements for Class II and Class III medical products.
• Able to travel up to 30%

Total Rewards

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

• The Target Salary Range in the United States: $148,000 - $163,000 based upon experience, as well as an annual bonus opportunity of 15% of base salary. Exact compensation may vary based on skills, experience, and locat
• 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.