Are you an experienced clinical research leader with a passion for advancing medical technology? We are seeking a Director of Clinical Monitoring (Medical Device) in Denver, CO, to oversee and enhance clinical trial operations, ensuring compliance with regulatory standards and optimizing trial outcomes. This executive role demands a strategic professional who excels in managing clinical monitoring teams, implementing best practices, and driving operational efficiency in the medical device sector.
As the Director of Clinical Monitoring (Medical Device) in Denver, CO, you will be responsible for leading clinical monitoring activities across multiple studies, ensuring data integrity, regulatory compliance, and efficient trial execution. If you have extensive experience in clinical trial management and a deep understanding of FDA, ISO, and GCP guidelines, this is your opportunity to shape clinical monitoring strategies for an innovative medical device company.
About This Role
The Director of Clinical Monitoring (Medical Device) in Denver, CO plays a critical role in ensuring the success of clinical trials by overseeing site monitoring activities, maintaining compliance with regulatory requirements, and driving operational excellence. This position requires an expert in clinical research operations who can develop and execute monitoring plans, manage CRA teams, and collaborate with cross-functional departments to ensure high-quality trial execution.
With a strong focus on data integrity, patient safety, and regulatory adherence, the Director of Clinical Monitoring (Medical Device) in Denver, CO will work closely with clinical investigators, sponsors, and internal teams to optimize clinical trial efficiency. This is an exciting leadership opportunity for a seasoned professional who is eager to drive innovation in medical device clinical research while ensuring that trials meet the highest standards of compliance and quality.
Key Responsibilities – Director of Clinical Monitoring (Medical Device) in Denver, CO
1. Oversee Clinical Monitoring Operations
- Develop and implement clinical monitoring strategies to ensure high-quality trial execution.
- Monitor site performance and adherence to study protocols, regulatory guidelines, and GCP.
- Provide leadership and guidance to clinical monitoring teams across multiple studies.
2. Ensure Regulatory Compliance and Quality Standards
- Maintain compliance with FDA, ISO, GCP, and other international regulatory standards.
- Lead audit preparations and oversee responses to regulatory inspections.
- Ensure proper documentation, reporting, and adherence to clinical trial protocols.
3. Manage and Mentor Clinical Research Associates (CRAs)
- Supervise and support CRAs, ensuring consistent performance and professional growth.
- Develop training programs to enhance CRA expertise in clinical monitoring best practices.
- Conduct performance reviews and provide feedback to ensure high team efficiency.
4. Optimize Site Selection and Performance Management
- Evaluate and select clinical trial sites based on feasibility and compliance factors.
- Establish strong relationships with principal investigators and site coordinators.
- Monitor site performance metrics and implement corrective actions when necessary.
5. Collaborate with Cross-Functional Teams
- Work closely with clinical operations, data management, and regulatory affairs teams.
- Contribute to protocol development and clinical study design considerations.
- Ensure alignment between monitoring strategies and overall clinical program goals.
6. Drive Risk-Based Monitoring Strategies
- Implement risk-based monitoring approaches to optimize resource allocation.
- Utilize centralized monitoring tools and real-time data analysis to enhance trial oversight.
- Identify and mitigate risks proactively to ensure trial success.
7. Oversee Data Integrity and Patient Safety
- Ensure accurate and timely collection of clinical trial data.
- Address protocol deviations, adverse events, and other safety concerns.
- Maintain stringent quality control processes to uphold data integrity.
8. Develop and Improve Clinical Monitoring Processes
- Establish SOPs for clinical monitoring operations.
- Implement process improvements to enhance trial efficiency and cost-effectiveness.
- Stay updated on industry trends and regulatory changes to continuously refine strategies.
What The Client is Looking For in You
To excel as the Director of Clinical Monitoring (Medical Device) in Denver, CO, you should bring a combination of leadership, expertise in clinical trials, and a commitment to ensuring high-quality and compliant study execution. The ideal candidate will possess:
- Extensive Experience in Clinical Research & Monitoring – A strong background in managing clinical monitoring operations within the medical device industry, with a deep understanding of clinical trial processes, site management, and regulatory compliance.
- Regulatory & Compliance Expertise – In-depth knowledge of FDA regulations, ISO 14155, ICH-GCP, and other global regulatory standards governing medical device clinical trials.
- Strategic Leadership & Team Management – Proven ability to lead and mentor clinical monitoring teams, providing oversight and guidance to Clinical Research Associates (CRAs) and ensuring optimal performance.
- Strong Analytical & Problem-Solving Skills – Experience in risk-based monitoring, identifying site-related challenges, and implementing proactive solutions to ensure smooth trial execution.
- Effective Cross-Functional Collaboration – Ability to work seamlessly with clinical operations, regulatory affairs, data management, and investigational sites to ensure trial success.
- Proven Track Record of Clinical Trial Success – Demonstrated history of managing and optimizing clinical monitoring activities for medical device trials that meet or exceed industry and regulatory expectations.
- Strong Communication & Stakeholder Management – Ability to communicate effectively with internal teams, clinical investigators, sponsors, and regulatory bodies to drive trial progress.
- Commitment to Innovation & Process Improvement – A forward-thinking mindset, always seeking to implement best practices and improve clinical monitoring efficiencies.
Why This Opportunity Stands Out
This role presents an exciting leadership opportunity in clinical research within the medical device sector. As the Director of Clinical Monitoring (Medical Device) in Denver, CO, you will:
- Lead Clinical Monitoring for a Fast-Growing Medical Device Company – Be at the forefront of cutting-edge medical device trials, ensuring compliance and operational efficiency.
- Shape the Future of Clinical Research Strategies – Implement best practices, optimize monitoring approaches, and drive trial success through innovative methodologies.
- Competitive Compensation & Benefits – Enjoy a lucrative salary, performance-based incentives, and a comprehensive benefits package.
- Opportunity to Work in a Dynamic & Collaborative Environment – Engage with industry leaders, regulatory experts, and clinical investigators to drive excellence in medical device research.
- Direct Impact on Medical Advancements – Play a crucial role in bringing life-changing medical devices to market by ensuring high-quality clinical trial execution.
- Professional Growth & Development – Gain exposure to global clinical trial operations, regulatory interactions, and leadership opportunities within the company.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, particularly in clinical trial monitoring, regulatory compliance, and site management.
Q: Is relocation required for this position?
A: The role is based in Denver, CO. Candidates should be open to relocation or already residing in the area.
Q: What is the reporting structure for this role?
A: The Director of Clinical Monitoring (Medical Device) in Denver, CO will report directly to the VP of Clinical Operations and collaborate closely with cross-functional teams, including regulatory affairs and data management.
Q: What kind of leadership style is expected?
A: We seek a strategic and proactive leader who fosters collaboration, drives operational efficiency, and ensures high-quality clinical monitoring.
Q: What are the travel requirements for this role?
A: The role may require moderate travel to clinical sites, investigator meetings, and industry conferences.
Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in life sciences, nursing, or a related field, along with at least 8+ years of clinical monitoring experience in the medical device industry. Experience with FDA and international regulatory compliance is essential.
Q: How does this role contribute to the company’s overall success?
A: The Director of Clinical Monitoring (Medical Device) in Denver, CO plays a critical role in ensuring clinical trials are executed with precision, compliance, and efficiency, ultimately contributing to the successful approval and commercialization of medical devices.
Q: What is the expected timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include an introduction to company processes, clinical trials in progress, and leadership meetings.
What Remuneration Can You Expect from This Job?
As the Director of Clinical Monitoring (Medical Device) in Denver, CO, you can expect a highly competitive compensation package that reflects your leadership role and expertise in clinical trial management. The base salary for this position typically ranges between $160,000 – $200,000 per year, depending on experience, qualifications, and past achievements in overseeing clinical monitoring operations.
In addition to the base salary, this role offers performance-based bonuses tied to key clinical trial milestones, regulatory compliance success, and overall operational efficiency. Equity options or stock grants may also be available for top candidates, providing a long-term financial incentive aligned with company growth.
The comprehensive benefits package includes healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, paid time off (PTO), and executive-level perks such as professional development programs, travel allowances, and industry conference participation. For candidates relocating to Denver, relocation assistance may be offered to facilitate a smooth transition.
This opportunity provides not only a lucrative financial package but also the chance to lead clinical monitoring operations in an innovative medical device company, playing a pivotal role in advancing healthcare solutions.
How to Apply for This Director of Clinical Monitoring (Medical Device) Position in Denver, CO
If you are a seasoned clinical research leader with a strong background in clinical monitoring within the medical device industry, we invite you to apply for the Director of Clinical Monitoring (Medical Device) in Denver, CO. This is an exceptional opportunity to lead high-impact clinical trials and ensure regulatory compliance for cutting-edge medical technologies.
To apply, please submit your resume and a cover letter detailing your experience in clinical trial monitoring, regulatory compliance, site management, and team leadership.
This role offers a rewarding opportunity to drive clinical excellence, implement best practices, and contribute to the success of medical device clinical trials. Apply today to take the next step in your leadership career as a Director of Clinical Monitoring (Medical Device) in Denver, CO!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags: Director of Clinical Monitoring | Clinical Trials | Medical Device Clinical Research | Clinical Operations Leadership | Regulatory Compliance | Denver, CO Clinical Jobs | Site Monitoring
