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Senior Manager, Clinical Operations - Clinical Process Owner

7 hours, 52 minutes ago
Serbia, Slovakia, United Kingdom, Hungary, Poland, Romania
Senior
Operations Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 74

Description

  • Own governance, accountability, alignment, and lifecycle management for Clinical Operations processes across regions and functions.
  • Develop, review, harmonize, implement, and maintain SOPs, work instructions, tools, templates, and controlled process documentation.
  • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity.
  • Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into practical process solutions.
  • Lead cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, and Training teams.
  • Lead process implementation and change management, including impact assessments, stakeholder engagement, training, communications, adoption monitoring, and effectiveness evaluation.
  • Serve as a Clinical Operations subject matter expert for strategic initiatives, audits, inspections, CAPAs, process assessments, and operational improvement activities.
  • Support business development through proposals, budgets, contracts, bid defenses, and presentations of Clinical Operations capabilities.
  • Lead cross-functional working groups, process teams, and strategic improvement initiatives as needed.

Requirements

  • Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered.
  • 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 from assessment and design through implementation and effectiveness evaluation within a CRO environment.
  • Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.
  • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles.
  • Ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
  • Experience owning or leading Clinical Operations SOPs, work instructions, and controlled documentation through their full lifecycle.
  • Experience with process mapping, change management, Lean, or continuous improvement methodologies.
  • Expert understanding of Clinical Operations processes and their cross-functional interfaces.
  • Ability to translate regulatory and quality requirements into clear, proportionate, and operationally practical processes.

Benefits

  • Remote work available in the UK, Hungary, Poland, Romania, Serbia, or Slovakia.
  • Equal opportunity employer with reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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