Study Start-Up Lead: Clinical Trials Orchestrator

TFS HealthScience; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Professional growth opportunities

Job summary

TFS HealthScience is seeking a Study Start Up Lead in Poland to oversee end-to-end study start-up activities from award through site activation. You will coordinate timelines, comply with ICH-GCP, and work with Regulatory, Legal, and Project teams to drive on-time delivery.

Ideal candidates bring 4+ years in clinical research with start-up focus, excellent English communication, and strong organizational skills to manage multiple projects in a fast-paced environment.

Qualifications

• 4+ years of clinical research experience focused on study start-up.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience coordinating multiple projects in a fast-paced env.
• Proven written and spoken English communication skills.

Responsibilities

• Lead study start-up activities from award to site activation.
• Develop start-up plans, timelines, and milestones.
• Collaborate with Project Managers to identify risks and mitigations.
• Coordinate EC/IRB submissions and Health Authority requirements.
• Support site feasibility, activation, and greenlight processes.
• Negotiate clinical trial agreements with Legal and operations.
• Ensure study docs are complete and filed in TMF.
• Monitor start-up metrics and report progress to stakeholders.
• Contribute to SOPs, improvements, and BD activities.

Skills

Project coordination

Regulatory knowledge

English communication

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

TFS HealthScience is seeking a Study Start Up Lead in Poland to oversee end-to-end study start-up activities from award through site activation. You will coordinate timelines, comply with ICH-GCP, and work with Regulatory, Legal, and Project teams to drive on-time delivery.

Ideal candidates bring 4+ years in clinical research with start-up focus, excellent English communication, and strong organizational skills to manage multiple projects in a fast-paced environment.