Senior Clinical Operations Process Owner (Remote)

precisionmedicinegroup

Poland

On-site

PLN 180,000 - 280,000

Full time

7 days ago
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Job summary

Precision for Medicine is seeking a Senior Manager, Clinical Operations to lead governance and harmonization of processes across regions. The role focuses on lifecycle management of SOPs, templates, and related documentation, while supporting audits, CAPAs, and strategic initiatives as a senior SME.

Candidates can work remotely in the UK, Hungary, Poland, Romania, Serbia or Slovakia, with responsibility for cross-functional collaboration and program execution across global regions.

Qualifications

  • Bachelor's degree in life sciences, healthcare, clinical research, business, or a related field.
  • 5+ years of progressive clinical research or clinical operations experience in CRO/pharma.
  • Experience leading cross-functional/global process improvement initiatives from assessment through implementation.
  • Strong knowledge of ICH-GCP, regulatory expectations and inspection readiness.

Responsibilities

  • Serve as the Clinical Process Owner for Clinical Operations processes, ensuring governance across regions.
  • Lead development, review, harmonization, and maintenance of SOPs, work instructions, tools, templates, and related documentation.
  • Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to simplify workflows.
  • Translate regulatory requirements, ICH-GCP principles, quality standards into effective process solutions.
  • Lead cross-functional governance and decision-making, partnering with multiple functions.
  • Oversee process implementation and change management, including training and adoption monitoring.
  • Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings.

Skills

ICH-GCP knowledge
Cross-functional collaboration
Process improvement
GxP compliance

Education

Bachelor's degree in life sciences

Job description

Precision for Medicine is seeking a Senior Manager, Clinical Operations to lead governance and harmonization of processes across regions. The role focuses on lifecycle management of SOPs, templates, and related documentation, while supporting audits, CAPAs, and strategic initiatives as a senior SME.

Candidates can work remotely in the UK, Hungary, Poland, Romania, Serbia or Slovakia, with responsibility for cross-functional collaboration and program execution across global regions.

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