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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:

  • 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 timely resolution.
  • 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 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.
  • 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.#LI-CL1Qualifications

    • Bachelor's Degree and/or combination of education and experience necessary
    • 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 matrix organization.
    • Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.
    • Excellent negotiation, decision-making, communication (oral and written) and presentation skills

      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

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