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Manager, Clinical Trial Transparency at Biogen in Raleigh, North Carolina

Posted in Research 30+ days ago.

Type: Full Time





Job Description:

Job DescriptionAbout This Role The Manager, Clinical Trial Transparency (CTT) is responsible for the planning and implementation of processes, vendor oversight, and technology optimization to ensure we are communicating clinical trial information in a manner that is compliant, transparent, and meets various stakeholder needs. The Manager, Clinical Trial Transparency will lead process mapping, highlight dependencies, recognize information sources/data flow, and identify how the public and patients' need for information may evolve along the clinical development lifecycle. What You'll Do Collaborate across global functions to continuously improve the quality, efficiency, and overall performance of CTT processes while maintaining comprehensive SOP documentation and implement effective training. Process development will encompass procedures for the registration of protocols, disclosure of study results, and disseminating trial information to study participants and other stakeholder while supporting regulatory inspections as needed. Engage directly with CTT vendor/supplier on an ongoing basis, maintaining the vendor engagement manual, enforcing the appropriate governance structure, and implementing strong oversight. Conduct vendor meetings to review book of work, metrics, cycle times, issues, and to identify opportunities to advance a lean and simple operating model. The role may be appointed to represent Biogen on one or more vendor services Client Councils.Maintain a strong understanding of business needs and information/data flow to optimize the use of technology solutions. Liaise with their leadership and IT to execute the roadmap ensuring that each platform/tool is maintained to the latest version. This individual may be appointed to represent Biogen on one or more technology Client Councils.Who You Are You are passionate about process development and incorporating new technologies to improve the way we work. You are excited to support global cross-functional projects and work collaboratively to ensure alignment across multiple functions. QualificationsRequired SkillsBachelors with 5+ years in the pharma/biotech industrySolid understanding of the clinical development life cycle Must be knowledgeable of Clinical Trial Transparency and impact on study/program communication planning for various stakeholders. Previous work in an outsourced operating model/CROs and/or working with vendors Proficient at mapping processes to identify improvements or address gapsDemonstrate how best to leverage technology to optimize processExperience leading and as a team member supporting global cross-functional projectsPreferred SkillsSix sigma or other related credentials Additional InformationOur mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects usasa team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. Position is commensurate on experience.All your information will be kept confidential according to EEO guidelines.PDN-976aad5f-d215-4964-b4ea-7a8409578ab8


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