Teams at Alira Health

Manages clinical research studies from implementation through completion, ensuring compliance with approved scopes, budgets, ICH GCP guidelines, FDA regulations, and timelines. Serves as the primary sponsor contact, coordinates cross-functional study functions and vendors, supervises clinical staff and Associate Project Managers, prepares study documentation and reports, manages milestones and subject accrual, supports TMF reviews, and participates in audits and inspections.

Leads life sciences strategy consulting engagements, including market assessments, portfolio prioritization, commercial due diligence, and corporate growth strategy. Develops analytical frameworks, guides research and quantitative modeling, creates strategic storylines and client presentations, manages client relationships, and mentors junior consultants. Requires strong analytical, communication, project management, and client leadership skills across biotech, pharmaceutical, MedTech, diagnostics, and HealthTech sectors.

Independently conducts and oversees clinical trial site monitoring, including qualification, initiation, interim, and close-out visits. Ensures protocol, ICH GCP, regulatory, and SOP compliance; reviews source data, monitoring reports, regulatory documents, and investigational product accountability. Supports recruitment, issue resolution, audit preparation, study budgets, monitoring plans, and sponsor communications. Mentors CRAs, assists with training, and collaborates with project management, data management, and clinical teams.