Job Description

ABOUT THIS ROLE

The Manager, TMF System role is responsible for managing user access for Biogen’s eTMF system and working to create process efficiencies. This role sits within Global Clinical Operations as part of the TMF Team and collaborates cross-functionally with the TMF Business Admin, HR, and users to initiate and approve system access.  The Manager, TMF System partners with IT on improvement and optimization efforts for system access, ensuring integrity across our system access process.

WHAT YOU’LL DO

• Oversee and implement processes for user access to Biogen’s eTMF system
• Serve as the primary contact for HR, IT, and TMF system users for access and attestation requests
• Provide up-to-date information on user access for the eTMF system via reports and tracking tools
• Support the eTMF business administrator with system administration tasks
• Support projects related to eTMF system improvements and optimization

WHO YOU ARE

You love process improvements and are always looking to find a more efficient way to do something.  You have an interest in technology and how it can enable regulated processes.

Qualifications

REQUIRED SKILLS 

• Bachelors Degree
• 3+ years of experience with TMF systems 
• Technical writing proficiency
• Strong project management skills
• Ability to lead & facilitate meetings
• Excellent communicator

PREFERRED SKILLS

• Experience with Wingspan 
• ICH awareness (ICH 21 CFR part 11)

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. 

All your information will be kept confidential according to EEO guidelines.