Senior Clinical Line Manager (Medical)

TL;DR

Senior Clinical Line Manager (Medical): Managing and resourcing CRA teams for clinical trials with an accent on performance monitoring, GCP compliance, and operational quality. Focus on optimizing site trends through risk assessment, mentoring junior staff, and driving business results through KPI reporting.

Location: United States (Remote supported, Hybrid encouraged for those based near offices)

Company

hirify.global provides end-to-end consulting solutions to biotech, med device, and pharmaceutical organizations to de-risk and accelerate drug and device programs.

What you will do

• Supervise CRA study teams and manage workload and resource allocation for ongoing clinical trials.
• Monitor performance metrics, including trip report turnaround, query management, and TMF compliance.
• Oversee site trends via dashboard reviews and conduct risk assessments to ensure quality standards.
• Provide coaching, mentoring, and lead training programs for monitoring operations teams.
• Collaborate with Clinical Leads and Project Managers to report and escalate delivery issues.
• Ensure all activities comply with GCP, ICH guidelines, and regulatory requirements.

Requirements

• Bachelor's degree in life sciences, nursing, or a related discipline.
• Minimum 10 years of experience in clinical research.
• Minimum 5 years in a monitoring leadership role with direct report management.
• Proficiency in CTMS, EDC, IVRS, and eTMF systems.
• Strong understanding of SOPs, regional/global regulations, and GCP/ICH guidelines.
• Experience in change management initiatives.

Culture & Benefits

• Commitment to diversity, equity, and inclusion (DEI).
• Support for remote working with a preference for hybrid collaboration near office locations.
• Environment that encourages innovative, collaborative, and entrepreneurial spirits.
• Personalized application review process without the use of AI screening tools.