Senior Clinical Lead (Clinical Research)

Location: Raleigh, United States. Remote working is supported; employees within a reasonable commute of an office are encouraged to work on a hybrid basis.

Company

hirify.global provides consulting and operational solutions for biotech, medical device, and pharmaceutical organizations across the product lifecycle.

What you will do

• Oversee investigator site management, monitoring activities, and clinical monitoring teams through 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 and oversee the quality of clinical monitoring deliverables.
• Contribute to clinical study plans, monitoring plans, study-specific training, tools, and templates.
• Coordinate site performance activities, including recruitment, site payments, study materials, status reporting, and cross-functional issue resolution.

Requirements

• Advanced-level CRA experience and at least 5 years of clinical research experience preferred.
• Prior LCRA or Clinical Lead experience is preferred.
• Demonstrated ability to lead clinical operations teams and manage, mentor, and develop junior staff.
• Experience building effective relationships with study site personnel and influencing them to achieve study goals.
• Experience with Microsoft Office, eTMF, CTMS, EDC, DCT, and other clinical trial systems.
• Strong knowledge of SOPs, work instructions, regional regulations, ICH guidelines, and GCP; a bachelor's degree is preferred.

Culture & Benefits

• Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment that encourages innovative, collaborative, and entrepreneurial contributions.
• Applications are personally reviewed by the recruitment team, with an outcome provided to every applicant.

Hiring process

• Applications are reviewed personally by a member of the recruitment team.
• Applicants receive an outcome regardless of whether they are selected.