Specialist, Informed Consent Management

About This Role

This role is part of the Informed Consent Management (ICM) team within Quantitative Sciences & Development Operations (QSDO) and will support timely delivery of Biogen’s clinical trials during Study Start Up and Maintenance. This team defines and oversees the process to ensure that ICFs are of high quality and delivered on time to meet key study milestones, such as submission to regulatory authorities and IRBs/Ethics Committees (ECs). As part of the QSDO operational model, the ICM team work collaboratively with Contract Research Organizations (CROs), who are responsible for the development and submission of ICFs. This role reports to the Head of Informed Consent Management and Clinical Trial Transparency.

What You’ll Do

• As Subject Matter Expert, monitor the ICF Mailbox to identify, manage, and provide resolution or triage incoming requests; Liaison with key ICF stakeholders, e.g., legal counsel, data privacy officer, and pharmacovigilance scientists, to support timely resolution of complex ICF Issues.
• Coordinates meetings (e.g., CRO, internal) by ensuring that the logistics are arranged. Ensures the preparation of necessary materials as well as the transcription and distribution of meeting minutes.
• Support continuous improvement of ICF process. This includes collection and analysis of IRB/EC and sites requests and development of hybrid sponsor/country or sites ICFs and guidelines to better satisfy local requirements.
• Assist in data collection and analysis for ICM and CRO performance metrics. This includes ensuring data accuracy and dashboard analysis, reporting, contributing with ideas for process improvement and supporting implementation of approved changes.
• Support cross-functional process improvement initiatives and ensures that the needs of the ICM process are considered.
• Support the maintenance of Standard Operating Procedures and Work Instructions for the IC process, consistent with Quality Documentation requirements and GCO standards.

Who You Are

You enjoy coordinating various activities and bringing information/data together to tell a story and support decision making. You see the value in maintaining high-quality, easily understandable materials that enable potential trial participants to make informed decisions.

Required Skills

• 3 - 5 years’ experience in the biotechnology/pharmaceutical industry or relevant healthcare experience. Leveling is dependent on experience.
• Bachelor’s Degree and/or combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities for the position.
• Experience in Clinical Operations, particularly in Study Delivery/Start Up, and a good understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
• Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.

Preferred Skills

• Knowledge of the Informed Consent process in clinical trials, including creation and adaptation of ICFs to local requirements, liaise and negotiate ICFs between study sites, sponsors, CROs and IRB/ECs.
• Experience with eConsent and supporting technologies, such as use of videos and multimedia components, in the consent process.

Why Biogen?

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.

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.