Start Up Lead (Pharma)

TL;DR

Start Up Lead (Pharma): Managing global site start-up activities and execution of activation strategies with an accent on IRB/EC and CA/MoH submissions. Focus on coordinating critical path planning, mitigating risks to timelines, and mentoring staff on local regulations.

Location: Remote from UK, Hungary, Poland, Romania, Serbia, or Slovakia

Salary: 209,300 – 313,900 PLN gross per annum

Company

A global Contract Research Organization (CRO) specializing in precision medicine and clinical trial execution.

What you will do

• Develop and execute site activation readiness strategies and critical path planning.
• Coordinate IRB/EC and CA/MoH submissions, including ICF customization and approval.
• Collaborate with stakeholders to align operational goals and ensure timely site activation.
• Manage project milestones, resources, and budgets while tracking progress metrics in real-time.
• Act as a Subject Matter Expert (SME) for country-specific start-up requirements and regulatory guidelines.
• Mentor and train staff on local study start-up procedures and SSDL.

Requirements

• Bachelors degree in life sciences, Registered Nurse (RN), or equivalent experience.
• 5+ years of experience in site start-up as a Lead within a CRO or pharma/biotech industry.
• 2+ years of experience in project milestone and resource management.
• Fluency in English and the local language of the country where the position is based.
• Strong knowledge of GCP/ICH Guidelines and applicable regulatory requirements.

Culture & Benefits

• Discretionary annual bonus and private medical insurance.
• Home working allowance and MultiSport Card.
• Life insurance, pension, and vacation.
• Flexible remote work environment within specified European countries.