Senior Manager, Clinical Operations – Clinical Process Owner

🔥 11 hours ago

🇵🇱 Poland – Remote

💵 zł304.5k - zł456.7k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. • Own the development, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and related process documentation. • Serve as Clinical Process Owner, ensuring effective governance, clear accountability, lifecycle management, and alignment across regions and functions. • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity. • Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into process solutions. • Lead cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions. • Lead process implementation and change management, including impact assessment, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation. • Serve as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support. • Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, and represent process capabilities to prospective clients. • 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. • At least 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment. • Proven 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. • Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization. • Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation. • Experience with process mapping, change management, Lean, or continuous improvement methodologies. • Expert understanding of Clinical Operations processes and their cross-functional interfaces. • Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes.

🏖️ Benefits

• Discretionary annual bonus • Private medical insurance • MultiSport Card • Life insurance • Pension • Home working allowance • Vacation