Senior Specialist, Country Study Start Up (Clinical Research)

Location: Maidenhead, England, United Kingdom

Company

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

What you will do

• Drive timely, high-quality country and site start-up and maintenance activities across assigned studies.
• Develop site activation plans, priorities, risk assessments, and mitigation plans for complex protocols.
• Collect and quality-check essential documents and prepare ethics, regulatory, informed consent, patient-facing, and safety reporting packages.
• Coordinate regulatory submissions, approvals, contracts, site activation timelines, clinical supply shipments, IP release, and site activation in IXRS.
• Maintain country and site intelligence, essential document lists, performance metrics, and KPIs in Vault SSU.
• Lead process improvements, training, change management, and mentoring for Specialists, Country Start Up.

Requirements

• Bachelor's degree in healthcare or a scientific field, or equivalent experience.
• Senior clinical research and study start-up management experience in the designated region.
• Hands-on experience interpreting regional clinical research regulations and processes.
• Experience working with central and local IRBs/ECs, sites, informed consent forms, and approval workflows.
• Experience with Vault SSU, including essential document processing, IP release, and ICF IRB/EC review.
• Working knowledge of ICH and GCP guidelines, strong analytical skills, and the ability to manage multiple priorities.

Culture & Benefits

• Work in a cross-functional clinical research environment with regulatory, clinical trial, contract, monitoring, and country study start-up teams.
• Participate in innovation, process improvement, training, and change management initiatives.
• Support audit and inspection readiness while working in alignment with worldwide regulations and corporate policies.
• Equal opportunity employment and a stated commitment to integrity, innovation, and community service.