Назад
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18 часов назад

Senior Manager, Clinical Operations

147 300 - 220 900$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
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
Senior Manager, Clinical Operations (Clinical Process Governance): Leading the governance, harmonization, and continuous improvement of Clinical Operations processes, including SOPs, work instructions, tools, templates, and process documentation, with an accent on ICH-GCP, regulatory compliance, and cross-functional alignment. Focus on resolving process gaps, implementing change management, supporting audits and inspections, and translating quality requirements into scalable operational processes.

Location: Remote, United States

Salary: $147,300–$220,900 USD annually, plus discretionary annual bonus

Company

hirify.global operates in clinical research and global clinical outsourcing.

What you will do

  • Own governance, accountability, harmonization, and lifecycle management for Clinical Operations processes across regions and functions.
  • Lead the development, review, implementation, and maintenance of SOPs, work instructions, tools, templates, and controlled process documentation.
  • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity.
  • Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into practical process solutions.
  • Lead cross-functional governance, change management, stakeholder engagement, training, communication, and adoption monitoring.
  • Serve as a senior Clinical Operations SME for audits, inspections, CAPAs, strategic initiatives, process assessments, and business development activities.

Requirements

  • Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered.
  • 5+ years of progressive clinical research or Clinical Operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.
  • Experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation.
  • Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.
  • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles.
  • Ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.

Nice to have

  • Experience owning or leading Clinical Operations SOPs, work instructions, and controlled documentation.
  • Experience with process mapping, change management, Lean, or continuous improvement methodologies.
  • Expert understanding of Clinical Operations processes and cross-functional interfaces.
  • Ability to translate regulatory and quality requirements into proportionate, operationally practical processes.

Culture & Benefits

  • Remote work arrangement within the United States.
  • Health insurance, retirement savings benefits, life insurance, and disability benefits.
  • Parental leave, paid sick leave, and vacation.
  • Eligibility for a discretionary annual bonus.

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