OverviewAbout This Role As an Associate Clinical Country and Site Lead (ACCSL), you will play a pivotal role in aligning country-specific operational and scientific insights to drive clinical development strategies. You will be embedded within the team responsible for enhancing local partnerships and ensuring the seamless execution of the Biogen Development pipeline. In collaboration with the Director of CCSL and other senior members, you will provide study teams with detailed local operational expertise and ensure that local opportunities and needs are woven into the operational plans. Positioned as a single point of contact for investigators, affiliate office staff, CRO staff, and global teams, your efforts will be vital in delivering high-quality clinical trials with a focus on patient safety and oversight of CRO activities. Additionally, you will serve as the site escalation point for investigator concerns, ensuring efficient communication and resolution of issues related to data integrity and patient safety.
What You’ll Do
Maintain up-to-date local knowledge of therapeutic and disease areas researched by Biogen.
Provide and manage investigator and site knowledge to highlight country-level capabilities and needs.
Support local activities in the country and site selection process, ensuring input from local treating physicians.
Act as primary country-level contact for development and execution of country activities related to CRO oversight.
Lead interactions for QSDO clinical studies, ensuring timely information flow and issue resolution.
Monitor and understand overall trial and country progress to support QSDO deliverables and goals.
Support local projects or other CSO activities as a country representative.
Who You Are
You are an insightful and customer-focused professional with a strong ability to build relationships across diverse cultures and teams. Your excellent interpersonal skills and high emotional intelligence enable you to collaborate effectively and navigate complex scenarios. You possess a keen ability to manage multiple priorities and thrive in a dynamic environment, consistently ensuring high-quality execution. Your passion for clinical research and your commitment to patient safety drive your work, and your organizational skills allow you to align priorities and set clear goals.
Required Skills
Minimum 5 years of clinical research experience.
Experience managing clinical trial activities, particularly sponsor oversight in an outsourced model.
Understanding of the cross-functional drug development process and scientific knowledge across key therapeutic areas.
Understanding of ICH/GCP and applicable country regulations.
Strong organizational and project management skills.
Proficiency with relevant IT tools for virtual team collaboration.
Excellent communication skills, including English proficiency where applicable.
Preferred Skills
Experience in sponsor oversight activities in a CRO/vendor model.
High emotional intelligence and cultural awareness.
Collaborative decision-making approach.
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 our DE&I efforts.
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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