Senior Site Start-Up Lead, Clinical Ops

Takeda; Warszawa; On-site; PLN 180,000 - 300,000; Full time

Job summary

Takeda in Warsaw, Poland seeks an experienced Site Start Up professional to independently manage complex trial start up activities. You will lead planning, country and site selection, and collaborate with CROs and internal teams to drive Ready to Enroll status.

The role emphasizes data-driven forecasting, adherence to GCP, and mentoring FSP colleagues, with responsibilities spanning end-to-end site initiation and process improvement across programs.

Qualifications

• 4+ years in Clinical Operations or project management.
• 2+ years leading site activation or start-up processes.
• GCP knowledge and regulatory awareness.
• Ability to analyze data and forecast timelines.
• Experience with FSP models is desirable.
• European Site Start Up experience preferred.

Responsibilities

• Establish and deliver the Site Start Up Plan.
• Lead the Site Start Up team to Ready to Enroll status.
• Partner with Clinical Operations teams to improve site start up metrics.
• Provide guidance across Clinical Programs including site selection and planning.
• Oversee data collection and analysis to drive forecasts.
• Ensure consistent standards across portfolios and improve processes.
• Manage collaboration with sponsors and CROs to address delays.
• Support and supervise FSP colleagues in site start up activities.
• Ensure compliance with GCP and regulatory requirements.

Skills

Clinical Operations

Site Start Up

Project Management

Data‑driven decision making

Tools

Software models

Database structures

Job description

Takeda in Warsaw, Poland seeks an experienced Site Start Up professional to independently manage complex trial start up activities. You will lead planning, country and site selection, and collaborate with CROs and internal teams to drive Ready to Enroll status.

The role emphasizes data-driven forecasting, adherence to GCP, and mentoring FSP colleagues, with responsibilities spanning end-to-end site initiation and process improvement across programs.