At a Glance
- Tasks: Lead clinical monitoring, ensuring high-quality trial execution and compliance.
- Company: Join a mid-sized biotech company dedicated to changing lives through innovative medicines.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Embrace a culture of inclusion and belonging with excellent growth opportunities.
- Why this job: Make a real-world impact in clinical research while leading a passionate team.
- Qualifications: Bachelor's in life sciences and extensive clinical monitoring experience required.
The predicted salary is between 40500 - 49500 £ per year.
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.
- Act as a subject matter expert on monitoring execution for internal and external partners.
- Identify and escalate site performance issues, conduct trend analysis, and ensure issue resolution per plan.
- Generate monitoring plans, site blinding and training plans, and trip report completion annotations.
Who You Are:
- You are a proactive leader with a keen eye for detail and a passion for clinical research.
- 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.
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field; 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.
- 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.
- 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.
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. 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. 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.
Location: Maidenhead, United Kingdom
Type: Full time
Contract Management Leader F/H in Maidenhead employer: Biogen Idec
At Biogen, we pride ourselves on being an exceptional employer, offering a dynamic work culture that values individual contributions and fosters professional growth. Located in Maidenhead, our mid-sized biotechnology company provides employees with the stability of an established business while encouraging innovation and collaboration to deliver life-changing medicines. With a strong commitment to inclusion and belonging, we empower our team members to thrive in their roles and make a meaningful impact in the field of clinical research.
