Associate Director, Clinical Trial Transparency (C

Job Description

About This Role The Associate Director (AD), Clinical Trial Transparency (CTT) Program Lead is integral to the Patient Engagement, Equity and Transparency team at Biogen and is responsible for the strategic planning and oversight of communication of clinical trial information to various stakeholders including study participants, patients, HCPs, and the public -for one or more disease Delivery Unit. On an ongoing basis, the AD will engage with members of the Delivery Unit and Program/Study Teams to identify the patient and other stakeholder needs for trial information at all stages along the clinical development lifecycle, while ensuring the impact to corporate functions (investor relations, scientific communication, public affairs) is assessed and understood. What You'll Do

• Work with the Delivery unit, Program and Study leads to establish the strategy for clinical trial transparency activities which may include
  • compliance with global disclosure requirements on public websites (clinicaltrials.gov, EU registry, EMA policy 0070, Health Canada, EU CTR)
  • public inquiry management (through collaboration with Medical Information/Patient Center)
  • sharing data with study participants (treatment assignments, aggregate lay results summaries, individual patient data)
    • data sharing with researchers (PhRMA/EFPIA)
    • communication with patient advocacy organizations to ensure trial information is readily available
    • alignment with journal publications
      • Ensure that the sharing of trial information is consistent the principles of safeguarding patient privacy; respecting the integrity of national regulatory systems.
      • Process Improvement activities including input into vendor management optimisation
        • Lead and support global projects and may represent Biogen on external working groups. The AD should stay informed of the evolving CTT and PE landscape, including regulatory requirements, numerous trade association commitments, and industry trends. Who You Are You are a clinical trial transparency subject matter expert with a passion for patient centricity to help patients connect with clinical trials and their outcomes in a timely and lay friendly way. Qualifications
          
          Required Skills
          • MUST have 3-5 years experience in the clinical trial transparency registry within a sponsor organization.
          • Bachelors degree with 6+ years OR Associates degree with 8+ years OR HSD with 10+ years of clinical research / project management experience including clinical site and CRO or sponsor experience.
          • Advanced knowledge of global regulatory environment and submission processes, global clinical transparency regulations (e.g., EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation), and emerging principles/guidelines governing clinical transparency
            • Strong understanding of regulations and guidance's as they pertain to transparency and disclosure
            • Experience in Lay Language Summaries.
            • Experience of working with clinical trial transparency vendors and CRO partners
            • Strong project management skills
            • Demonstrated ability to work in a cross functional team
              • Redaction and anonymization knowledge, including solid understanding of data privacy regulations
              • Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills
              • Strong ability prioritize multiple deadlines and projects
              • Excellent written and verbal communications skills Preferred Skills
                • Experience of relating clinical trial transparency to patient engagement.
                • Knowledge of Data Sharing
                  
                  Additional Information
                  
                  All your information will be kept confidential according to EEO guidelines.

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