(Senior) Clinical Study Manager, Clinical Development

Location: Research Triangle Park, United States

Salary: $100,000–$140,000 per year

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical and genomic insights to support treatment decisions.

What you will do

• Lead the end-to-end management of prospective observational trials and retrospective real-world evidence studies.
• Develop study protocols, informed consent forms, case report forms, and study-specific manuals.
• Oversee CROs, central laboratories, and clinical trial sites, including site identification and feasibility assessments.
• Maintain relationships with Principal Investigators and coordinate study operations.
• Partner with Data Science and Bioinformatics teams to ensure high-quality data collection and clean retrospective-analysis datasets.
• Track milestones, budgets, and risks while coordinating with Medical Affairs, Product, Legal, and Engineering.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related field; an MS, MPH, or PhD is preferred.
• 5+ years of clinical trial management experience in a biotech, pharmaceutical, or CRO environment.
• Strong understanding of oncology and/or molecular diagnostics.
• Experience with EDC systems, CTMS, and eTMF platforms.
• Knowledge of ICH-GCP guidelines, HIPAA regulations, and clinical SOPs.
• Exceptional project management, communication, and problem-solving skills.

Nice to have

• Experience with real-world data or retrospective cohort studies.
• Familiarity with SQL or data visualization tools.
• Advanced degree in a relevant field.

Culture & Benefits

• Fast-paced startup environment.
• Benefits may include incentive compensation, restricted stock units, medical coverage, and other benefits depending on the position.