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Biogen

Senior Clinical Trial Transparency Specialist

УдалённоUnited States только
Опубликовано
Роль
Операции
Опыт
Синьор
Размер компании
Средняя
$116k–$155k/yr
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Доступно для: US only. Укажите, откуда вы работаете, чтобы проверить доступность.

Коротко по делу

Senior clinical trial transparency specialist with 4+ years in the pharmaceutical industry and 2+ years of clinical trial transparency experience. Must be US-based (Remote, USA) and experienced in clinical trial registration, results disclosure, vendor management and transparency systems. Will lead disclosure planning and ensure timely, compliant registry reporting.

Ключевые навыки

Clinical trial registrationResults disclosure

Обязательные навыки

Vendor managementProcess mappingClinical Trial Transparency systems and toolsPlain language summariesStakeholder managementQuality oversight and monitoring

Желательные навыки

Experience supporting or leading SOP or work-instruction updatesFamiliarity with data sharingPatient engagementHealth equityDigital engagement

Чем предстоит заниматься

  • Lead disclosure planning and delivery for assigned clinical studies
  • Coordinate protocol registration, record maintenance, and results disclosure activities
  • Serve as the primary Clinical Trial Transparency contact for assigned study teams
  • Partner with vendors to deliver accurate, timely, high-quality registry disclosures
  • Monitor vendor workload, performance metrics, cycle times, and issue logs
  • Escalate disclosure risks, dependencies, and quality concerns as appropriate
  • Support planning, coordination, and quality review of plain language summaries
  • Improve Clinical Trial Transparency processes, work instructions, SOPs, and training
  • Provide user feedback and support testing for Clinical Trial Transparency technology solutions
  • Represent the function on cross-functional initiatives and continuous-improvement projects

Что требуется

  • Bachelor’s degree in a science related field
  • 4+ years of relevant pharmaceutical-industry experience or equivalent
  • 2+ years experience of global clinical trial transparency knowledge and disclosure requirements
  • Experience with clinical trial registration and results disclosure activities
  • Understanding of clinical study and program communication-planning dependencies
  • Process mapping and continuous improvement experience
  • Vendor-management experience in an outsourced operating model
  • Ability to monitor deliverables, quality, timelines, metrics, and issues
  • Familiarity with Clinical Trial Transparency technology, systems, and tools
  • Knowledge of plain language summaries and patient-centered trial communication
  • Strong cross-functional communication and stakeholder-management skills
  • Preferred: Experience supporting or leading SOP, work-instruction, or training updates
  • Preferred: Familiarity with data sharing, patient engagement, health equity, or digital engagement

Преимущества

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation

American multinational biotechnology company

BiotechСредняяbiogen.com/
$116k–$155k/yr