Назад
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2 дня назад

Senior Manager, Clinical Operations

147 300 - 220 900$
Формат работы
remote (только Canada)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Canada
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, SOPs, work instructions, tools, and templates with an accent on regulatory compliance, ICH-GCP, quality standards, and cross-functional alignment. Focus on designing scalable processes, resolving conflicting requirements, managing implementation and change, and supporting audits, inspections, CAPAs, and strategic initiatives.

Location: Remote, Canada

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

Company

hirify.global provides clinical research and clinical outsourcing services across pharmaceutical, biotechnology, and healthcare environments.

What you will do

  • Own governance, accountability, alignment, and lifecycle management for Clinical Operations processes across regions and functions.
  • Lead the development, review, harmonization, 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, communications, and adoption monitoring.
  • Provide senior Clinical Operations subject-matter expertise 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.
  • 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 related 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 clear, proportionate, and operationally practical processes.

Culture & Benefits

  • Remote work arrangement in Canada.
  • Health insurance and retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave, paid sick leave, and paid vacation.
  • Eligibility for a discretionary annual bonus.

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