Study Start-Up Lead, Dermatology Trials

TFS HealthScience; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

TFS HealthScience in Poland is seeking a Study Start Up Lead to drive initiation activities from award through site activation. You will coordinate start-up plans, timelines, and milestones, ensuring projects stay on time and within budget while adhering to ICH-GCP and regulatory requirements.

The role requires strong organizational and communication skills, plus four years in clinical research. You will manage EC/IRB submissions, site feasibility, contract negotiations, and documentation, while

Qualifications

• 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 activities.
• Good understanding of ICH-GCP guidelines and regulatory requirements.
• Experience coordinating multiple projects in a fast-paced environment.
• Strong organizational, planning, and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Good to have: Experience in submissions in the US and Australia.

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 collaborate with Regulatory teams on Health Authority requirements.
• Support site feasibility, site activation, and greenlight processes.
• Coordinate clinical trial agreement negotiations alongside Legal and operational teams.
• Ensure study documentation is complete, accurate, and submitted to the Trial Master File.
• Monitor start-up metrics and provide regular progress updates to project stakeholders.
• Support continuous improvement initiatives, SOP development, and operational best practices.
• Contribute to bid defenses, proposals, and business development activities when required.

Skills

Study start-up

Regulatory submissions

Project coordination

ICH-GCP knowledge

English proficiency

Multi-project management

Education

Bachelor's degree

Job description

TFS HealthScience in Poland is seeking a Study Start Up Lead to drive initiation activities from award through site activation. You will coordinate start-up plans, timelines, and milestones, ensuring projects stay on time and within budget while adhering to ICH-GCP and regulatory requirements.

The role requires strong organizational and communication skills, plus four years in clinical research. You will manage EC/IRB submissions, site feasibility, contract negotiations, and documentation, while