Clinical Trial Lead (IVD)

Location: Hybrid role based in Marlborough, Massachusetts, United States, with onsite work required three days per week

Annualized base salary: $116,500–$182,200, plus bonus eligibility

Company

hirify.global develops diagnostic technologies supporting women’s health, infectious disease, and oncology.

What you will do

• Plan and execute clinical operations for simple to complex clinical trials.
• Lead the work of Clinical Research Associates and Clinical Trial Assistants while ensuring compliance with GCP, regulations, and procedures.
• Develop clinical monitoring plans, informed consent documents, study tools, and CRA training materials.
• Lead site identification, selection, start-up, regulatory document collection, IRB approval, budget negotiations, and contract execution.
• Track enrollment, site performance, expenses, timelines, operational metrics, and compliance issues.
• Manage Trial Master File quality and implement continuous process improvements.

Requirements

• Bachelor’s degree in Life Sciences or an equivalent qualification.
• At least 6 years of progressive clinical research experience in an industrial setting.
• Experience managing moderate to complex clinical studies.
• Advanced knowledge of clinical trial practices, regulations, clinical operations, and monitoring management.
• Advanced knowledge of clinical trial databases and proficiency with technical computer systems.
• Ability to lead and influence people without direct authority.

Nice to have

• Experience in an in vitro diagnostics environment.

Culture & Benefits

• Comprehensive training is provided upon joining.
• Continued development and training are available throughout the career.
• Bonus eligibility is included with the base salary.