Global Study Start-Up & Regulatory Leader

ERGOMED; Kraków; On-site; PLN 180,000 - 280,000; Full time

Job summary

Ergomed is a specialist clinical research organization focusing on rare disease and oncology trials, offering complex, high-quality regulatory services. The Manager, Study Start Up and Regulatory Affairs leads SSU and regulatory activities, provides strategic guidance, and mentors junior staff across global projects.

The role involves coordinating site selection through activation, ensuring regulatory compliance, and contributing to bids and proposals to win new business.

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• 6–8 years within pharmaceutical or CRO industry or Regulatory body.
• At least 3 years in a leading/project management role, proven ability to manage global projects.

Responsibilities

• Lead study start-up and regulatory activities for medium to high complexity projects.
• Provide strategic regulatory guidance, training, coaching and mentoring to junior staff.
• Negotiate and execute clinical site agreements and amendments within timelines.
• Identify and mitigate regulatory risks to timelines and deliverables.

Skills

Regulatory affairs

Project management

Cross-functional leadership

Education

Graduate degree in Chemistry or Life Sciences

Nursing (or equivalent)

Job description

Ergomed is a specialist clinical research organization focusing on rare disease and oncology trials, offering complex, high-quality regulatory services. The Manager, Study Start Up and Regulatory Affairs leads SSU and regulatory activities, provides strategic guidance, and mentors junior staff across global projects.

The role involves coordinating site selection through activation, ensuring regulatory compliance, and contributing to bids and proposals to win new business.