Senior Manager, Clinical Operations - Clinical Process Owner
Thuiswerken
Over de functie
Precision Medicine Group is looking for a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance and continuous improvement of Clinical Operations processes. This remote role focuses on developing and maintaining SOPs, work instructions, tools, and templates while translating regulatory requirements into practical process solutions.
Wat ga je doen
- Lead governance and continuous improvement of Clinical Operations processes
- Develop and maintain SOPs, work instructions, tools, and templates
- Identify and resolve process gaps and inconsistencies
- Translate regulatory requirements into process solutions
- Lead cross-functional process governance and decision-making
- Act as senior SME for audits, inspections, and strategic initiatives
Wat je meebrengt
- Bachelor's degree in life sciences, healthcare, clinical research, business, or related field
- 5+ years of progressive clinical research or operations experience in CRO, pharma, biotech, or global clinical outsourcing
- Experience leading complex cross-functional or global process improvement initiatives in a CRO environment
- Strong knowledge of clinical trial operations, monitoring, site management, and cross-functional trial delivery
- Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness
- Ability to influence stakeholders and drive outcomes in a matrix organization
Mooi meegenomen
- Experience owning or leading development and lifecycle management of Clinical Operations SOPs and controlled documentation
- Experience with process mapping, change management, Lean, or continuous improvement methodologies
- Expert understanding of Clinical Operations processes and cross-functional interfaces
- Ability to interpret regulatory and quality requirements into practical processes
Over Precision Medicine Group
Precision Medicine Group is a specialized company focused on precision medicine solutions.
Samenvatting door Personeel.com. De volledige vacaturetekst en het sollicitatieformulier staan op de website van Precision Medicine Group (job-boards.greenhouse.io); met Solliciteer ga je er direct heen.