Senior Manager, Clinical Operations - Clinical Process Owner
New
P
Precision for MedicineClinical Research
Candidates can work remotely in the UK, Hungary, Poland, Romania, Serbia or Slovakia.Full-TimeManager
Salary not disclosed
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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, pharmaceutical, or biotechnology environment.
- Proven experience leading complex cross-functional or global process improvement initiatives.
- Strong knowledge of clinical trial operations, clinical monitoring, and site management processes.
- Strong knowledge of ICH-GCP, regulatory expectations, and inspection readiness principles.
- Demonstrated ability to influence stakeholders, facilitate decisions, and resolve conflicts in a matrix organization.
- Experience owning the development and lifecycle management of SOPs and work instructions (preferred).
- Experience with process mapping, change management, Lean, or continuous improvement methodologies (preferred).
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations, ensuring governance and lifecycle management of all process documentation.
- Lead the development, review, and harmonization of SOPs, work instructions, tools, and templates.
- Identify and resolve process gaps, duplication, and inconsistencies to improve operational scalability.
- Translate regulatory requirements and quality standards into effective, practical process solutions.
- Partner with cross-functional teams including Quality Assurance, Regulatory, and Project Management to facilitate process decision-making.
- Lead process implementation and change management, including stakeholder engagement and adoption monitoring.
- Support strategic initiatives, audits, inspections, and business development activities as a subject matter expert.
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