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
- Quality AssuranceChange 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, biotechnology, or global clinical outsourcing environment.
- Demonstrated experience leading complex cross-functional or global process improvement initiatives from design through implementation.
- Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional delivery processes.
- Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles.
- Proven ability to influence stakeholders, facilitate decisions, and drive outcomes in a matrixed organization.
- Experience with process mapping, change management, Lean, or continuous improvement methodologies (Preferred).
- Expert understanding of Clinical Operations processes and their cross-functional interfaces (Preferred).
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations, ensuring effective governance, accountability, and process alignment.
- Lead the development, review, and maintenance of SOPs, work instructions, tools, and templates.
- Identify and resolve process gaps, inconsistencies, and complexity to establish scalable workflows.
- Translate regulatory requirements, quality standards, and stakeholder feedback into effective process solutions.
- Represent Clinical Operations in cross-functional process governance, partnering with Quality Assurance, Regulatory, and other teams.
- Lead change management initiatives, including impact assessments, training requirements, and adoption monitoring.
- Act as a subject matter expert for audits, inspections, and business development proposals, budgets, and bid defense meetings.
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