Biogen
About This Role
As an Associate Clinical Country & Site Lead, you will be in an external-facing, country-aligned clinical operations position focused on providing key local operational and scientific knowledge to support country-level clinical development strategy. You will help enable local partnerships, enhance customer satisfaction, and support the focused delivery and execution of Biogen’s development pipeline.
You will work closely with the Director, Clinical Country & Site Lead, as well as the Clinical Country & Site Lead or Senior Clinical Country & Site Lead in country, to provide study teams with detailed local operational and scientific knowledge that supports clinical operations execution. You will ensure that local opportunities, needs, and insights are thoughtfully integrated into operational plans.
You will serve as a single point of contact for investigators, affiliate office staff, CRO staff, and QSDO/global teams, helping enable the delivery of local clinical trials with a strong focus on quality, patient safety, and oversight of CRO activities and performance.
You will also act as a site escalation point for investigator concerns, including issues related to data integrity, data quality, patient safety, or matters unresolved by the CRO, ensuring these are communicated to the appropriate Biogen responsible party.
What You'll Do
Maintain up-to-date local knowledge of Biogen’s therapeutic areas, standards of care, clinical trial requirements, and the needs of local investigators and research sites.
Build and maintain strong relationships with investigators and sites, helping position Biogen as a partner of choice for clinical research.
Support country and site selection activities by gathering local insights and feedback from investigators and other key stakeholders.
Act as the primary country-level QSDO/Biogen contact for sponsor oversight activities, including Sponsor Oversight Visits (SOVs), audits, inspections, and CRO oversight.
Perform co-monitoring activities during Sponsor Oversight Visits, ensuring trial records, informed consent documentation, and source documents are maintained in accordance with protocol, ICH-GCP, SOPs, and local regulations.
Lead interactions with investigators, affiliate teams, CRO staff, and global stakeholders to facilitate information flow and timely issue resolution across clinical studies.
Monitor and assess overall trial and country performance to support QSDO objectives and country-level goals.
Contribute to local projects and broader Clinical Study Operations activities as a representative of the country.
Who You Are
You are a collaborative and adaptable clinical research professional who thrives in a matrix environment. You bring strong relationship-building skills, sound judgment, and a proactive approach to problem-solving. You are eager to learn, comfortable navigating ambiguity, and able to manage multiple priorities while maintaining a strong focus on quality, patient safety, and stakeholder experience. Above all, you are motivated by the opportunity to contribute to clinical research and help bring innovative medicines to patients.
Required Skills
University degree or the equivalent combination of education with a science background and experience required.
Minimum 5 years clinical research experience. Experience managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced /FSP model with CROs/vendors.
Understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling aCCSL to discuss compound (s), development plans, and protocol endpoints with investigator site personnel.
Understanding of ICH/GCP, applicable country regulations and clinical trial monitoring in an outsourced model.
Strong organizational skills, especially project management skills, with an ability to set clear goals, align priorities and execute on multiple tasks/activities.
Effective working knowledge of relevant IT tools to promote virtual team working.
Excellent knowledge of clinical operational activities/challenges across local geography.
Ideal candidate will be customer-focused, with excellent interpersonal skills, cultural awareness, high emotional intelligence and a collaborative decision-making approach. Must build relationships throughout and across the organization whilst operating remotely.
Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities. Strong communication skills, including English language skill in countries where English is not the primary language. Ability to assimilate new knowledge rapidly.
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.