The Clinical Support Manager is responsible for managing local SOP, TMF plan, relevant systems/process for clinical operation, Quality oversight of clinical trial, supporting for planning and conducting global annual audit plans, and all activities to maximize clinical operation capability across studies for Japan.
He/She collaborates with multiple functions in Quantitative Sciences and Development Operations (QSDO) and R&D Quality & Compliance (RDQC) to be consistent with global process and also work within and outside R&D such as global/local finance or sourcing team.
He/She serves as the leader of the Japanese inspection response team responsible for preparing for and responding to inspection conducted by PMDA. Also he/she acts as the primary point of contact for the global inspection team and regulatory authorities, leading the coordination of inspection responses.
As part of vendor management responsibilities, he/she collaborates with stakeholders both within and outside the R&D department, such as Japan Study Lead (JSL), Clinical Financial Planner (CFP), Global/Local finance, and sourcing teams, to be responsible for budget management and contract management processes of local CROs and vendors.
Job Level: Management
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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