7 дней назад
Senior Manager, Clinical Operations - Clinical Process Owner
304 500 - 456 700PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Clinical Operations - Clinical Process Owner (Clinical Research): Governing and improving Clinical Operations processes, SOPs, work instructions, and controlled documentation across regions and functions with an accent on ICH-GCP compliance, process harmonization, and scalable clinical trial delivery. Focus on translating regulatory and quality requirements into practical processes, leading cross-functional change initiatives, and supporting audits, inspections, CAPAs, and business development activities.
Location: Remote in the UK, Hungary, Poland, Romania, Serbia, or Slovakia
Salary: PLN 304,500–456,700 gross per annum, plus a discretionary annual bonus
Company
provides precision medicine clinical research services, integrating clinical operations, laboratory expertise, and advanced data sciences for therapeutic development, including oncology and rare disease programs.
What you will do
- Own governance, accountability, harmonization, and lifecycle management for Clinical Operations processes.
- Develop, review, implement, and maintain SOPs, work instructions, tools, templates, and related controlled documentation.
- Identify process gaps, duplication, inconsistencies, and unnecessary complexity, then implement scalable improvements.
- Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, and operational data into practical process solutions.
- Lead cross-functional process governance, stakeholder engagement, change management, training, communication, and adoption monitoring.
- Provide Clinical Operations expertise for audits, inspections, strategic initiatives, process assessments, proposals, budgets, contracts, and bid defense meetings.
Requirements
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered.
- At least 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 through assessment, design, implementation, and effectiveness evaluation within a CRO environment.
- Strong knowledge of clinical trial operations, clinical monitoring, site management, cross-functional trial delivery, ICH-GCP, regulatory expectations, quality standards, and inspection readiness.
- 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 their cross-functional interfaces.
Culture & Benefits
- Remote work in selected European countries.
- Private medical insurance and life insurance.
- MultiSport Card and pension benefits.
- Home working allowance and vacation benefits.
- Eligibility for a discretionary annual bonus.
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