Senior Manager, Clinical Operations
New
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Precision for MedicineClinical Research
Remote, United KingdomFull-TimeManager
Salary147,300 - 220,900 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- Change ManagementProcess improvement
Requirements
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or equivalent experience.
- 5+ years of progressive clinical research or clinical operations experience in a CRO, pharma, biotech, or global outsourcing environment.
- Proven experience leading complex cross-functional or global process improvement initiatives.
- 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.
- Demonstrated ability to influence stakeholders, facilitate decisions, and drive outcomes in a matrix organization.
- Experience owning or leading the development and lifecycle management of Clinical Operations SOPs 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 interpret regulatory and quality requirements into practical processes.
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, and alignment across regions and functions.
- Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, and templates.
- Identify and resolve process gaps, inconsistencies, and complexity to establish clear, scalable ways of working.
- Translate regulatory requirements, ICH-GCP principles, and audit findings into effective process solutions.
- Lead cross-functional process governance, partnering with Quality Assurance, Regulatory, Data Management, and other departments.
- Manage process implementation and change management, including stakeholder engagement, training, and adoption monitoring.
- Act as a senior Clinical Operations SME for audits, inspections, strategic initiatives, and business development support.
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