Senior Clinical Line Manager

Location: United States; remote working is supported, with hybrid office collaboration encouraged for employees living within a reasonably short commute of an office.

Company

hirify.global provides consulting and operational solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Support resourcing for CRAs and clinical operations staff across planned and ongoing clinical trials.
• Supervise assignments, workloads, performance, monitoring-plan compliance, trip reports, action items, queries, data currency, and TMF management.
• Review dashboards, assess site risks and trends, and conduct or support co-monitoring and oversight visits.
• Develop study and program plans, monitoring training programs, tools, and process improvements.
• Coach, mentor, and develop monitoring personnel and junior staff.
• Coordinate with Clinical Leads, Project Managers, and internal and external stakeholders while tracking milestones, timelines, KPIs, and escalations.

Requirements

• Bachelor’s degree required, preferably in life sciences, nursing, or a related discipline.
• At least 10 years of clinical research experience, including 5 years in monitoring leadership with direct-report management.
• Extensive knowledge of SOPs, work instructions, regional and global regulations, ICH Guidelines, and GCPs.
• Experience with CTMS, EDC, IVRS, eTMF, and Microsoft Office applications.
• Strong communication, presentation, leadership, prioritization, stakeholder-management, and KPI-reporting skills.
• Demonstrated experience in change management and developing efficiency-improving tools and processes.

Culture & Benefits

• Remote working is supported, with in-person collaboration encouraged where practical.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, innovation, and entrepreneurship.
• Applications are personally reviewed by the recruitment team without AI screening tools.
• Applicants receive an outcome from the recruitment process.