Director, Site Start Up (Clinical Research)

TL;DR

Director, Site Start Up (Clinical Research): Leading site start-up operations for global clinical trials with an accent on regulatory submissions, site contracts, delivery governance, and cross-functional execution. Focus on building scalable SSU frameworks, managing complex programs and escalations, optimizing KPIs and processes, and developing high-performing teams.

Location: Remote within the United Kingdom, Spain, Poland, Hungary, Serbia, Slovakia, or Romania.

Company

hirify.global provides precision medicine clinical research services, integrating clinical operations, laboratory expertise, and advanced data sciences for therapeutic development, with experience in oncology and rare disease.

What you will do

• Lead and provide strategic direction for the Site Start-Up department, including people, processes, systems, and delivery performance.
• Oversee site start-up activities such as informed consent form adaptation, regulatory document review, IRB/EC and Competent Authority submissions, and site contract and budget negotiations.
• Establish SSU frameworks, tools, methodologies, risk evaluations, and mitigation plans with the Head of Site Start Up.
• Coordinate SSU execution with Clinical Operations, project management, Business Development, resourcing, and regional functional leaders.
• Lead complex programs, manage escalations, improve delivery processes, and develop SSU KPIs and continuous improvement initiatives.
• Support team development, succession planning, client presentations, proposals, budgeting, and bid defense activities.

Requirements

• Bachelor’s degree in life sciences or a related field, or an equivalent combination of education, training, and experience.
• At least 12 years of clinical research experience, including extensive Site Start-Up experience.
• Experience working for a Clinical Research Organisation and managing people and resources.
• Expert knowledge of GCP, ICH guidelines, and the clinical development process.
• Demonstrated leadership, strategic planning, risk management, change management, communication, and organizational skills.
• Fluency in English and experience with Microsoft Office and clinical systems such as CTMS, eTMF, and EDC.

Culture & Benefits

• Remote work available from the listed European countries.
• Work within a global precision medicine clinical research organization.
• Opportunity to contribute to clinical trials from early development through approval.
• Role focused on quality, client service, team engagement, performance, and continuous improvement.