Local Trial Manager (Clinical Development)

Location: US - California - Thousand Oaks; Flex Commuter / Hybrid. The position may telecommute.

Annual salary: $138,320–$163,992 per year.

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Plan, manage, and oversee local and country-level clinical study implementation in line with global program strategy.
• Lead the cross-functional Local Study Team and coordinate global and local country teams.
• Develop and monitor Country Operational Plans, study timelines, milestones, enrollment forecasts, and performance metrics.
• Oversee CROs and other external vendors, including laboratories, imaging vendors, and IRT providers.
• Support regulatory submissions, audits, inspections, CAPA activities, and issue resolution.
• Maintain study progress transparency through status communication and relevant clinical systems.

Requirements

• Master’s degree or foreign equivalent in Drug Regulatory Affairs, Biology, Chemistry, or a related field.
• At least 3 years of experience in the offered role or a clinical trial-related occupation.
• Experience applying ICH E6 Good Clinical Practice and related ICH guidelines in global clinical trials.
• Experience interpreting FDA regulations, including 21 CFR Parts 11, 50, 54, 56, and 312.
• Experience with clinical trial start-up through close-out, regulatory submissions, risk-based quality management, data integrity, and CAPA.
• Experience using Medidata Rave, Veeva Vault TMF, CTMS, and IRT/IWRS/IVRS systems.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus eligibility and stock-based long-term incentives.
• Paid time-off plans, flexible work models, and career development opportunities.