Senior Specialist, Country Study Start Up

Location: North Chicago, Illinois, United States. Conditions: Shanghai, China.

Company

hirify.global discovers and delivers medicines and solutions for serious health conditions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Drive the timely, high-quality execution of study start-up and maintenance activities for assigned countries, sites, and complex protocols.
• Build site activation plans, assess risks, coordinate priorities, and communicate delivery issues with cross-functional stakeholders.
• Collect and quality-check essential documents, prepare ethics and local regulatory packages, and coordinate ICF and patient-facing material approvals.
• Coordinate regulatory submissions, contract activities, site activation timelines, clinical supply shipments, IP release, green-light letters, and IXRS activation.
• Maintain country intelligence, essential document libraries, performance metrics, and KPIs in Vault SSU while supporting audit and inspection readiness.
• Lead process improvements and provide subject-matter expertise, training, and mentoring to Country Start-Up Specialists.

Requirements

• Bachelor's degree, preferably in healthcare or a scientific field, or equivalent experience.
• At least 3 years of clinical research experience, preferably including 2 or more years in study start-up management for the designated region.
• Hands-on experience interpreting regional clinical research regulations and working with central and local IRB/EC sites.
• Experience with Vault SSU for essential document processing, IP release, and ICF and IRB/EC review.
• Working knowledge of ICH and GCP guidelines and the country's regulatory environment.
• Strong analytical, critical-thinking, prioritization, collaboration, and decision-making skills.

Culture & Benefits

• Work with remote and virtual teams across clinical research functions.
• Operate within an environment focused on integrity, innovation, compliance, and improving patient outcomes.
• Participate in change management and the adoption of new technologies and processes.