Clinical Trials Lead

The role

You will own the planning and running of Salma Health's clinical studies, from start-up through close-out. You will lead clinicians, researchers and operations partners to run compliant trials on schedule.

What you will do

• Lead end-to-end operations of clinical trials, from start-up and site activation through enrollment, monitoring and close-out
• Develop and manage study plans, timelines and budgets, and keep leadership informed of progress, risks and trade-offs
• Partner with clinical, research and data teams to turn protocols into practical operational plans
• Oversee participant recruitment, screening, scheduling and retention while protecting the participant experience
• Oversee IRB submissions, informed consent and study documentation so every study is inspection-ready
• Select and manage external partners and vendors, holding them to standards for quality and delivery
• Ensure study conduct follows the protocol, Good Clinical Practice and applicable regulations, and resolve deviations and quality issues promptly
• Build and improve systems, templates and workflows so the research program can run multiple studies at once
• Lead, mentor and develop study coordinators and research staff

Required qualifications

• At least 5 years of clinical research or clinical trial operations experience, including managing studies from start-up through close-out
• Working knowledge of ICH-GCP and human subjects research requirements, including IRB processes and informed consent
• Demonstrated project management skills, including managing timelines, budgets and several priorities at once
• Experience overseeing CROs, research sites or other external vendors
• Excellent written and verbal communication skills, working across clinical, scientific and operational teams
• Comfort building structure in a fast-paced, evolving environment, with high integrity and sound professional judgment
• Ability to travel to Salma Health clinics about 40% of the time

Nice to have

• Experience with neuroscience, psychiatry, or neurology studies, or with interventional or device-based trials
• Experience in a startup or growth-stage organization, or a professional certification such as ACRP, SOCRA or PMP

Benefits

• Medical, dental and vision coverage
• PTO
• Additional benefits, which the company may modify in accordance with applicable law
• Discretionary bonus and/or stock option grants

Before you apply

• Sponsorship for employment authorization may be considered case by case, depending on the role and candidate qualifications
• Applicants with arrest and conviction records will be considered under the California Fair Chance Act

About the company

Salma Health is a brain health company that combines care delivery, technology innovation and research to better understand, diagnose and treat brain disorders. It aims to replace a fragmented approach to brain healthcare with an end-to-end system under one roof.