Clinical Trial Manager (SaMD)

TL;DR

Clinical Trial Manager (SaMD): Leading end-to-end execution of regulated clinical trials for Software as a Medical Device (SaMD) with an accent on FDA-cleared feature development and clinical evidence generation. Focus on managing CROs, ensuring regulatory compliance, and coordinating cross-functional teams to unlock new product capabilities.

Location: Remote (United States only). Candidates must reside in the US, excluding AK, DE, IA, MS, NE, SD, WV, and WI.

Salary: $79,900 – $110,000 (based on geographic tier).

Company

hirify.global is a health technology company that empowers people to own their inner potential through award-winning wearable products and actionable health insights.

What you will do

• Own end-to-end planning and execution of regulated clinical trials from start-up through close-out.
• Lead sponsor-side CRO and vendor management, including selection, onboarding, and performance oversight.
• Partner with Science, Product, Engineering, Regulatory, and Legal teams to align study execution with product goals.
• Translate study requirements into operational plans, documentation, and core management tools.
• Ensure high-quality evidence generation through data review, cleaning, and database lock processes.
• Identify emerging risks and develop contingency plans to keep trials on track.

Requirements

• 3+ years of full-time experience leading clinical trials end-to-end in an industry setting.
• Strong experience in regulated medical device or SaMD trials, including ICH-GCP and ISO 14155.
• Expertise in managing multiple data streams such as EEG, CGM, ePRO, and wearables.
• Proven experience with clinical operations systems like EDC, eCOA, eTMF, and CTMS.
• Must be based in the United States (excluding specific states).
• Flexibility for occasional travel and global team calls outside normal business hours.

Nice to have

• Experience managing decentralized human subject research studies.
• Experience supporting regulatory submissions with the FDA or international regulators (e.g., EU MDR).
• Experience supporting regulatory audits for study compliance.

Culture & Benefits

• Competitive salary and equity packages.
• Comprehensive health, dental, vision insurance, and mental health resources.
• 20 days of paid time off, 13 paid holidays, and 8 days of flexible wellness time off.
• hirify.global Ring provided for all employees plus discounts for friends and family.
• Supportive, collaborative, and low-ego team culture.