Biogen
Clinical Monitoring Lead
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About This Role
As a Clinical Monitoring Lead, you will be at the forefront of ensuring high-quality trial execution and regulatory compliance within assigned studies. Your role is pivotal in leading the clinical monitoring function, providing direct oversight and operational leadership to Site Managers (SMs) and Clinical Trial Coordinators (CTCs). You will ensure effective monitoring of clinical sites, adherence to ICH-GCP and SOPs, and timely resolution of study issues. By supporting operational readiness for inspection, maintaining data integrity, and ensuring operational consistency across monitoring activities, you will contribute significantly to the success of our clinical trials. This position offers an opportunity to make a real-world impact by driving excellence in clinical monitoring and collaborating closely with Quality Assurance and other stakeholders.
What You’ll Do
- Lead and manage Site Managers in all aspects of site monitoring, including site selection, initiation, routine monitoring, and close-out.
- Review monitoring visit reports and follow-up letters for accuracy, completeness, and compliance with protocol, SOPs, and regulatory requirements.
- Ensure consistent application of risk-based and centralized monitoring strategies across studies.
- Track and report on site performance, enrollment, data quality, and issue resolution.
- Ensure timely and accurate documentation in the Trial Master File (TMF) and support audit and inspection readiness.
- Partner with Quality Assurance to conduct root cause analyses and implement corrective and preventive actions (CAPAs).
- Supervise, coach, and mentor Site Managers, conducting performance reviews and supporting professional development.
- Deliver Site Manager training on protocol requirements, therapeutic area knowledge, and monitoring best practices.
- Collaborate with CTDU, CTAU, and other stakeholders to align on trial execution operational strategies.
- Act as a subject matter expert on monitoring execution for internal and external partners.
- Complete trip report reviews in compliance with study plan timelines.
- Identify and escalate site performance issues, conduct trend analysis, and ensure issue resolution per plan.
- Perform accompanied site visits with site managers, as applicable, and attend sponsor meetings to discuss country/region startup progress, trends, and issue escalation.
- Generate monitoring plans, site blinding and training plans, and trip report completion annotations.
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Who You Are
You are a proactive leader with a keen eye for detail and a passion for clinical research. Your ability to mentor and guide teams ensures that every study you oversee is conducted with precision and excellence. You thrive in a collaborative environment, where your communication skills foster strong relationships across the organization. Your adaptability allows you to manage multiple tasks efficiently, even amidst shifting priorities and tight timelines. With your strategic mindset, you drive performance and maintain high standards of compliance and quality in all monitoring activities.
Required Skills
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
- Extensive clinical monitoring experience with a strong background as a Clinical Research Associate (CRA).
- Proven experience in CRA management, mentoring, and monitoring oversight within a clinical research environment.
- Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines.
- Demonstrated experience in CRA performance management and inspection readiness.
- Excellent organizational, leadership, and problem-solving skills.
- Strong communication skills, both written and verbal.
- Willingness to travel (25–40%, as required).
- Ability to build relationships across the organization and operate effectively in a hybrid or remote environment.
- Proven ability to manage multiple tasks of varying complexity within tight timelines and shifting priorities.
- Strong leadership skills with the ability to influence and drive performance across clinical trial teams assigned.
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Preferred Skills
- Advanced degree in life sciences or related field.
- Experience with risk-based monitoring strategies.
- Familiarity with electronic Trial Master File systems and clinical trial management systems.
Job Level
Management
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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