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Job Details


Biogen

Associate Director, Functional TMF Quality

Life, Physical, and Social Science

All

Full Time

On Site

No

Cambridge, Massachusetts, United States

Job Description About this role As the Associate Director, Functional Trial Master File Quality, you will provide overall leadership, management and guidance of a robust record management process and tools to support an inspection ready Trial Master File (TMF) for Analytics and Data Sciences (ADS) and Global Clinical Operations (GCO). You will instill best practices in ADS and GCO processes and tools for overall records management. You will develop processes and training for ADS and GCO staff related to TMF responsibilities. In addition, you will manage and lead a team responsible for the quality and completeness of TMF documentation. You will collaborate with the TMF Process and Sub-Process Owners and other Functional TMF Leads to support standards of TMF quality, consistency, and timeliness. What you’ll do Provide operational leadership of the ADS and GCO TMF team (Quality Associates, Document Control Specialists); collaborate with ADS and GCO functional area management to understand and support the study timelines. You will support internal and external inspections and audits. Collaborate with the TMF Process and Sub-process Owners and other Functional TMF Leads in developing processes to support standards of TMF quality, consistency, and timeliness; verifying that the clinical trial documentation is consistent with the TMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agency requirements. Represent ADS and GCO on the TMF Core Team and /or TMF Council. Oversee quality of the ADS and GCO TMFs, including monitoring metrics and analytics and conducting quality checks. Proactively provide feedback to ADS and GCO leadership and staff in terms of how the quality and timeliness of the TMF Provide leadership, management, and guidance to direct reports. You are responsible for recruiting and hiring staff and contractors, conducting performance management, career development, compensation planning, etc. Who You Are: You have a passion for TMF and enjoy working with various stakeholders to enhance TMF awareness. You get excited by metrics, and enjoy developing and implementing process improvements based on what you learn from the metrics. Qualifications Required Skills: Bachelor’s degree preferably in a scientific discipline 12+ years’ experience in the biotechnology or pharmaceutical industry with a focus on Clinical Trial experience (such as Clinical Data Management, Biostatistics, Statistical Programing, or Clinical Operations experience) eTMF management experience Experience with CROs Experience managing staff and managing resources to meet changing timelines Knowledge of TMF best practices, TMF regulatory agency expectations, GCP and other regulations Preferred Skills: Wingspan/IQVIA eTMF experience highly preferred Additional Information Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a 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.