Senior Specialist, Informed Consent Management, Global Clinical Operations
Posted on: May 12, 2022
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
Manage and provide resolution when IRBs/ECs have requests to modify
a Biogen study ICF. Assess requests to determine appropriate
resolution and/or involvement of other stakeholders, e.g., legal
counsel, data privacy officer, pharmacovigilance scientists, for
Attend clinical study team meetings as required to support SSU
activities, liaising with representatives from Site Contracts,
operations, regulatory, and QA.
Support cross-functional process improvement initiatives and ensure
that the needs of the IC process are considered.
Monitor the informed consent process by CROs to ensure timeliness,
accuracy, and compliance with regulatory obligations and internal
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.
Support the maintenance of Standard Operating Procedures and Work
Instructions for the IC process, consistent with Quality
Documentation requirements and GCO standards.
Responsible for continued maintenance of user guidance tools,
training materials and report templates.
Bachelor's Degree and/or combination of education and experience
Five (5)+ years' experience in the biotechnology/pharmaceutical
industry or relevant healthcare experience.
Experience in Clinical Operations, particularly in Study
Delivery/Start Up, and a good understanding of GCP, relevant ICH
standards, and FDA/EMA guidelines.
Knowledge of the informed consent process in clinical trials,
including creation and adaptation of ICFs to local IRB
requirements, liaise and negotiate ICFs between study sites,
sponsors, CROs and IRB/ECs.
Demonstrated success in working cross functionally and in a global
Strong organizational skills, including the ability to prioritize
needs and handle a high volume of tasks within a given
Excellent negotiation, decision-making, communication (oral and
written) and presentation skills
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
Keywords: Biogen, Cambridge , Senior Specialist, Informed Consent Management, Global Clinical Operations, Executive , Cambridge, Massachusetts
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