Senior Clinical Lead

Location: Remote; hybrid work may be available for new hires within a reasonably short commute of a hirify.global office, subject to manager agreement.

Company

hirify.global provides consulting and operational expertise 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

• Oversee investigator site management, monitoring activities, and clinical monitoring teams throughout study startup, execution, and closeout.
• Act as the lead site management resource for clients, investigational sites, and internal study teams.
• Ensure monitoring activities comply with study plans, SOPs, GCP/ICH guidelines, and applicable regulations.
• Review and approve site visit reports, monitor monitoring quality, and conduct quality co-monitoring visits when required.
• Contribute to clinical study plans, monitoring plans, training materials, study tools, and templates.
• Lead site performance activities involving recruitment, site payments, study materials, reporting, and cross-functional issue resolution.

Requirements

• Advanced ability to perform CRA activities and lead clinical operations professionals in clinical trial execution.
• At least 5 years of clinical research experience is preferred, including CRA experience; prior LCRA or Clinical Lead experience is preferred.
• Experience managing, mentoring, and developing junior staff.
• Strong relationship-building, communication, interpersonal, and presentation skills.
• Bachelor’s degree preferred; equivalent education, training, and experience may be considered.
• Experience with Microsoft Office, eTMF, CTMS, EDC, DCT, SOPs, regional regulations, ICH guidelines, and GCP.

Culture & Benefits

• Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Employees are encouraged to contribute innovative, collaborative, and entrepreneurial ideas.
• Applications are reviewed personally by the recruitment team rather than by AI screening tools.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.