Managing medical and emergency response operations at a remote industrial site for International SOS. Leading teams, client delivery, compliance, quality, equipment, and emergency preparedness.
About the role
- Senior Manager governing clinical operations processes for Precision Medicine Group’s clinical research services. Leading SOP harmonization, compliance, process improvement, and cross-functional clinical delivery.
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, lifecycle management, and alignment across regions and functions.
- Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation.
- 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 effective process solutions.
- Lead and represent cross-functional process governance and decision-making across 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 and communication requirements, adoption monitoring, and evaluation of process effectiveness.
- Act as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support, including proposals, budgets, contracts, bid defense meetings, and client presentations.
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.
- Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness 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 principles.
- Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
- 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
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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