As a Manager in Informed Consent Management (ICM), you will lead and support cross-functional teams that develop/implement processes, support key projects and initiatives, and ensure compliance with internal processes and external requirements.  You will support all studies within the Biogen portfolio and will work across all global regions.  As ICM is an integral part of Study Start-up (SSU) within Global Clinical Operations (GCO), you will provide strategic project and study level support to meet clinical study milestones.

What You’ll Do:

• Provide SME support during SSU at the study planning stage, as well as throughout the lifecycle of a clinical study through oversight of Biogen’s CRO Partners to ensure compliant and timely consent of subjects.
• Analyze project/study team requirements, activity timelines and work scope to identify resource needs.
• Lead monitoring of controlled process documents for compliance with Biogen policies and changes in laws and regulations.
• Monitor the informed consent process by CROs to ensure timeliness, accuracy, and compliance with regulatory obligations and internal KQIs.
• Produce and analyze KQI metrics on compliance, performance, and quality. Evaluate trends and identify areas of improvement.
• Provide SME support on quality issues resolution, regulatory inspections and QA Audits.
• Lead and support cross-functional projects, focusing on process improvement.
• Identify, evaluate, and oversee third party vendors.

• Bachelor’s Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position.  
• 8 years experience in the biotechnology/pharmaceutical industry or relevant healthcare experience.
• 2 years leadership and project management experience
• Experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards and FDA/EMA regulations.
• Experience in authoring/reviewing ICF documents and/or other patient-facing material, health literacy experience, knowledge of ICF requirements (ICH GCP, local and national requirements).
• Excellent negotiation skills, conflict resolution and decision making skills, communication (oral and written) and presentation skills.
• Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.
   

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.   

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