Specialist, Country Study Start Up

Location: Shanghai, China

Company

hirify.global develops innovative medicines and solutions addressing serious health issues across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Drive timely, high-quality start-up and maintenance activities for assigned studies and sites.
• Establish country and site activation plans, priorities, risk assessments, and mitigation plans with cross-functional partners.
• Collect and quality-check essential documents and compile ethics, regulatory, informed consent, patient-facing, and safety reporting packages.
• Coordinate regulatory submissions, approvals, contract activities, site monitoring, and IRB/EC comment resolution.
• Trigger clinical supply shipments, complete investigational product release activities, issue site green-light letters, and activate sites in IXRS.
• Maintain study intelligence, performance metrics, KPIs, audit readiness, and updates in Vault SSU.

Requirements

• Bachelor's degree; a healthcare or scientific degree is highly preferred, or equivalent experience.
• 1–2 years of clinical research experience, preferably including at least 1 year of study start-up management experience in the designated region.
• Experience working with remote or virtual teams and managing multiple priorities in a fast-paced environment.
• Strong interpersonal, communication, flexibility, and adaptability skills.
• Working knowledge of ICH and GCP guidelines and the country's regulatory environment.

Culture & Benefits

• Work with cross-functional regional and global clinical research teams.
• Participate in process improvement initiatives.
• Opportunity to train and mentor new Country Start-Up Specialists.
• Work in an organization committed to integrity, innovation, inclusion, and community service.