Start Up Lead (Clinical Trials)

Location: Fully remote from Serbia, Romania, Hungary, Slovakia or Poland; occasional travel may be required.

Company

hirify.global provides clinical research and pharmaceutical and biotechnology services.

What you will do

• Manage site start-up processes through activation readiness strategies, critical path planning and milestone oversight.
• Coordinate IRB/EC and CA/MoH strategies, ICF customization, contract execution and IMP release requirements.
• Collaborate with clients, functional leaders, site start-up specialists, regulatory teams, clinical operations and project management to deliver activities on time.
• Track study, country and site progress, maintain start-up systems and identify risks requiring mitigation.
• Coordinate required document translations and support country-specific start-up summaries, process flows and training.
• Act as a subject matter expert, mentor less-experienced staff and participate in client proposals and presentations.

Requirements

• Bachelor’s degree in life sciences or a related field, registered nurse qualification, or equivalent education, training and experience.
• At least 5 years of experience in clinical trial start-up, preferably in a Start Up Lead or project management role within a CRO, pharmaceutical or biotechnology organization.
• At least 2 years of experience managing project milestones, resources, budgets and team activities.
• Fluency in English and the local language of the country where based.
• Experience with milestone tracking systems, computerized information systems and cross-functional leadership.
• Knowledge of Good Clinical Practice, ICH Guidelines and applicable regulatory requirements.

Nice to have

• Advanced degree in life sciences or a related field.

Culture & Benefits

• Fully remote work from the listed European countries.
• Work in a cross-functional international clinical research environment.
• Opportunities to mentor colleagues and expand country start-up expertise.
• Occasional travel may be required.