Associate Clinical Country and Site Lead
About This Role: As an Associate Clinical Country and Site Lead (aCCSL), you will be at the forefront of driving local operational and scientific knowledge to support Biogen’s clinical development strategy at the country level. Reporting to the Director, CCSL, you will collaborate closely with CCSL or Sr. CCSL in your country to provide study teams with the insights necessary for seamless clinical operations. Your role is pivotal in ensuring that local opportunities and needs are integrated into operational plans, enhancing customer satisfaction and supporting the delivery and execution of our development pipeline. You will serve as a key liaison for Investigators, affiliate office staff, CRO staff, and QSDO/global teams, ensuring high-quality local clinical trials are conducted with a focus on patient safety and effective oversight. This position also involves serving as a site escalation point for investigator concerns, ensuring unresolved issues are communicated to the appropriate Biogen party.
What You’ll Do:
Maintain and update local knowledge of therapeutic and disease areas researched by Biogen.
Manage investigator and site relationships to highlight country-level capabilities and satisfaction levels.
Develop and execute country-level QSDO investigator engagement strategies.
Support local activities in the country and site selection process.
Act as primary country-level QSDO/Biogen contact for sponsor oversight of CRO and clinical trial activities.
Perform co-monitoring tasks during Sponsor Oversight Visits (SOVs).
Lead interactions for timely local information flow with Investigators and affiliate office staff.
Monitor and analyze overall trial and country progress to support QSDO deliverables.
Support local projects or other CSO activities as a representative of your country.
Who You Are: You are someone with a deep understanding of clinical research and the drug development process. You thrive in dynamic environments and excel at fostering relationships across diverse teams. Your ability to communicate effectively and manage multiple priorities enables you to deliver results efficiently. You are customer-focused, with excellent interpersonal skills, and possess a high level of cultural awareness and emotional intelligence. Your collaborative decision-making approach and ability to assimilate new knowledge rapidly make you a strong fit for this role.
Required Skills:
Minimum 5 years clinical research experience.
Experience managing clinical trial activities, especially sponsor oversight activities.
Understanding of cross-functional drug development process and high scientific/clinical knowledge.
Knowledge of ICH/GCP and applicable country regulations.
Strong organizational and project management skills.
Effective working knowledge of relevant IT tools for virtual team collaboration.
Excellent knowledge of clinical operational activities across local geography.
Strong communication skills, including English proficiency in non-English speaking countries.
Preferred Skills:
Experience in an outsourced/FSP model with CROs/vendors.
Customer-focused with excellent interpersonal skills and cultural awareness.
Proven ability to handle tasks of varying complexity within a given timeframe.
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.