Senior Clinical Line Manager

TL;DR

Senior Clinical Line Manager (Clinical Research): Support study teams by resourcing and supervising clinical monitoring staff, ensuring CRA performance, site delivery quality, and compliance with GCP and regulatory requirements. Focus on continuous monitoring of KPIs and risk, leading process and quality improvement initiatives, and coaching/mentoring monitoring personnel to achieve clinical operations milestones and timelines.

Company

hirify.global provides end-to-end clinical research and regulatory science consulting services across the product lifecycle.

What you will do

• Support study teams with resourcing and assignment/workload oversight for CRAs and other clinical operations staff.
• Continuously monitor performance against clinical monitoring plan compliance, trip report turnaround and quality, action/query management, data currency, and TMF management.
• Manage site trends via dashboard review and ongoing risk assessment to maintain quality standards and address site delivery concerns.
• Lead monitoring operations oversight, including milestone/timeline leadership and oversight/co-monitoring visits and CRA training support as needed.
• Compile and report individual and team KPIs across CRA/site monitoring teams and drive insights for business improvement.
• Coach, mentor, and develop junior staff; lead and author training programs for monitoring operations teams; propose proactive solutions and change-management initiatives.

Requirements

• Minimum 10 years of experience in clinical research, including at least 5 years in a monitoring leadership capacity with direct report management.
• Strong understanding of SOPs, Work Instructions, regional and global regulations, ICH guidelines, and GCP for clinical trial conduct.
• Experience with CTMS, EDC, IVRS, and eTMF systems.
• Excellent verbal and written communication skills, including presentation and stakeholder management across internal and external partners.
• Ability to prioritize multiple tasks, plan proactively, anticipate obstacles, and develop solutions to achieve project goals.
• Bachelor’s degree required (preferably life sciences, nursing, or related discipline).

Culture & Benefits

• Remote working supported; new hires within a reasonably short commute of an office are encouraged to work hybrid and spend some time in the office as agreed with the manager.
• Focus on diversity, equity, and inclusion, with an Equal Opportunity Employer approach.
• Applications are personally reviewed by the recruitment team, and candidates receive an outcome for their application.