Senior Specialist, Informed Consent Management, Gl
Company: Biogen
Location: Cambridge
Posted on: May 16, 2022
|
|
Job Description:
Job DescriptionJob Description
As the Senior Specialist, you will support the Informed Consent
(IC) process within Biogen and participate in the oversight of the
CRO to ensure the IC process meets the requirements of regulatory
authorities and IRBs/Ethics Committees, and to support Biogen's
compliance with quality standards and processes.You will liaise
with the CRO and study delivery teams to ensure Study Start Up
(SSU) timelines are met which involves engagement with study sites
and IRBs/ECs to finalize ICFs. What You'll Do:
Additional Information
This role is part of the Informed Consent (IC) team within Global
Clinical Operations (GCO) to support timely delivery of Biogen's
clinical studies 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 GCO operational model, the IC team work
collaboratively with Contract Research Organizations (CROs), who
are responsible for the development and submission of ICFs.Business
needs may require the Senior Specialist to take on other supporting
activities to ensure smooth and efficient functioning of the ICM
team. As required, act as a delegate for ICM Associate Director to
dispense his/her responsibilities.All your information will be kept
confidential according to EEO guidelines.
Keywords: Biogen, Cambridge , Senior Specialist, Informed Consent Management, Gl, Executive , Cambridge, Massachusetts
Click
here to apply!
|