18 часов 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, 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
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
2 дня назад
Clinical Trial Manager, Clinical Operations, Infectious Disease (Biotech)
109 200 - 174 600$
5 дней назад
Clinical Trial Manager/Senior Clinical Trial Manager (Biotech)
120 000 - 170 000$
16 часов назад
Clinical Research Manager II - Pediatric Stem Cell Transplant
94 500 - 113 700$
4 дня назад
Senior Clinical Line Manager
5 дней назад
Clinical Operations Manager Cluster South
2 дня назад
Study Oversight Senior Manager (Biotech)
167 187 - 226 194$