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Precision for Medicine seeks a Senior Manager, Clinical Operations to serve as Clinical Process Owner, leading governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. This is a senior individual contributor leadership role requiring cross-functional influence across regions and seniority levels.
Key responsibilities include:
- Serve as Clinical Process Owner ensuring effective governance, accountability, lifecycle management, and alignment across regions and functions
- Lead development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and documentation
- Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear, practical, scalable ways of working
- Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, and stakeholder feedback into effective process solutions
- Lead cross-functional process governance and decision-making, partnering 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, adoption monitoring, and effectiveness evaluation
- Act as senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, and business development support
Required qualifications:
- Bachelor's degree in life sciences, healthcare, clinical research, business, or related field (equivalent experience considered)
- 5+ years progressive clinical research or clinical operations experience in CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment
- Proven experience leading complex cross-functional or global process improvement initiatives from assessment through implementation and evaluation
- 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
- Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in matrix organizations
Preferred qualifications include experience owning or leading development and harmonization of Clinical Operations SOPs and controlled documentation, process mapping and continuous improvement methodologies (Lean), expert understanding of Clinical Operations processes and cross-functional interfaces, and ability to translate regulatory and quality requirements into operationally practical processes.
