2 дня назад
Senior Manager, Clinical Operations
147 300 - 220 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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