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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 organization
Preferred qualifications include experience owning/leading SOP development and harmonization, process mapping and continuous improvement methodologies (Lean), expert understanding of Clinical Operations processes and cross-functional interfaces, and ability to translate regulatory requirements into operationally practical processes.
