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9 дней назад

Associate Director, Clinical Trial Start-Up (Clinical Research)

164 800 - 247 200$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Director, Clinical Trial Start-Up (Clinical Research): Developing and overseeing global clinical trial start-up strategies, country and site activation plans, and CRO execution with an accent on data-driven planning, regulatory compliance, and operational risk mitigation. Focus on analyzing historical and predictive data, optimizing site activation timelines, and leading cross-functional improvements across clinical research programs.

Location: Remote/Home-Based in California or Philadelphia, Pennsylvania, United States. The role includes 10%–20% travel in the US and internationally.

Salary: $164,800–$247,200 annually for US-based candidates, with potential bonus, equity, and benefits eligibility.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

  • Lead or oversee study-level clinical trial start-up strategies, country and site activation plans, projections, and risk mitigation.
  • Use historical and predictive data, real-world evidence, analytics, and emerging technologies to optimize activation timelines and operational planning.
  • Provide subject-matter expertise on global study, country, and site start-up pathways, regulatory requirements, IRB/EC processes, and activation strategies.
  • Partner with cross-functional teams to support country and site selection, protocol implementation, timelines, and governance activities.
  • Oversee CROs, vendors, and SSU team members, including KPI tracking, training, guidance, and performance feedback.
  • Improve SSU policies, SOPs, tools, training, documentation quality, inspection readiness, and process efficiency.

Requirements

  • Bachelor’s degree in life sciences or a related field required; an advanced degree is preferred.
  • 8–10 years of clinical research experience, including at least 5 years focused on clinical trial start-up or site activation.
  • Expertise in global clinical site start-up, regulatory requirements, IRB/EC processes, and site activation pathways.
  • Experience leading or supporting global start-up strategies in in-house and outsourced models, including CRO or vendor oversight.
  • Strong analytical, strategic thinking, leadership, collaboration, communication, and cross-functional decision-making skills.
  • Proficiency with CTMS, document management systems, and SSU technology platforms such as Veeva Vault.

Nice to have

  • Experience assessing or using AI in clinical trial start-up.
  • Advanced degree in life sciences or a related field.

Culture & Benefits

  • Remote/home-based work arrangement with US and international travel.
  • Medical, dental, and vision insurance.
  • 401(k) retirement savings plan and flexible paid vacation.
  • Potential annual cash bonus or incentive compensation and discretionary equity grants.
  • Equal opportunity and affirmative action employment practices.

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