Study Start Up Lead - Dermatology

About the role

TFS HealthScience, a global mid-size Contract Research Organization (CRO), is hiring a Study Start Up Lead for its Dermatology team in Poland. The role leads and coordinates study start-up activities from award through site activation, ensuring projects are delivered on time, within budget and in compliance with regulations and quality standards.

Key responsibilities

• Lead and oversee study start-up activities across assigned projects from award to site activation.
• Develop and maintain start-up plans, timelines and project milestones.
• Partner with Project Managers to identify risks and implement mitigation strategies.
• Coordinate Ethics Committee (EC/IRB) submissions and work with Regulatory teams on Health Authority requirements.
• Support site feasibility, site activation and greenlight processes.
• Coordinate clinical trial agreement negotiations with Legal and operational teams.
• Ensure study documentation is complete, accurate and submitted to the Trial Master File.
• Monitor start-up metrics and give regular progress updates to stakeholders.
• Support continuous improvement, SOP development and operational best practices.
• Contribute to bid defenses, proposals and business development when required.

Required profile

• Bachelor's degree in Life Sciences, Nursing or a related field.
• Minimum 4 years of clinical research experience with a strong focus on study start-up.
• Experience coordinating multiple projects in a fast-paced environment.
• Good to have: experience in submissions in the US and Australia.

Required skills

• Good understanding of ICH-GCP guidelines and regulatory requirements.
• Strong organisational, planning and problem-solving skills.
• Excellent written and verbal communication in English.

What we offer

• A competitive compensation package.
• Comprehensive benefits.
• Opportunities for personal and professional growth.