Lead, Site Start-Up & Trial Readiness

Takeda Pharmaceutical Co.; Warszawa; On-site; PLN 150,000 - 190,000; Full time

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland seeks an experienced Site Start Up professional to work independently on complex clinical study start up tasks. You will analyze diverse data and guide teams, including FSP colleagues, to ensure on-time enrollment and compliant processes.

You will lead site activation, collaborate with Clinical Operations and partners, and drive data-driven forecasts while leveraging industry tools to improve timelines and quality across studies.

Qualifications

• 4+ years in Clinical Operations, Project Management, site start up or trial optimization with increasing responsibility.
• At least 2 years direct responsibility in site activation and start up processes for clinical studies.
• Expertise in country/site start up strategies and study start up concepts.
• Solid understanding of GCP and regulatory requirements.

Responsibilities

• Establish, develop and deliver the Site Start Up Plan.
• Lead the Site Start Up team to implement the plan and drive Ready to Enroll status.
• Partner with Clinical Operations and TAU to improve site start up metrics and performance.
• Provide guidance and oversight to the Site Start Up team across programs.
• Oversee data collection/analysis to forecast study start up timelines and benchmarking.
• Leverage tools to evaluate timelines, data quality and cycle times for decision making.
• Ensure standards across portfolios and drive continuous improvement of Site Start Up processes.
• Develop site start up strategies aligned with therapeutic needs.
• Agree deliverables with the team and address delays or non-performance.
• Resolve escalated issues in partnership with the Study Manager.
• Support FSP colleagues with site start up activities and issue resolution.
• Ensure compliance with GCP and regulatory requirements.

Skills

Site Start Up Plan

Team leadership

Regulatory knowledge

GCP knowledge

Data analysis

Stakeholder management

FSP experience

Process improvement

Job description

Takeda Pharmaceutical Co. in Warsaw, Poland seeks an experienced Site Start Up professional to work independently on complex clinical study start up tasks. You will analyze diverse data and guide teams, including FSP colleagues, to ensure on-time enrollment and compliant processes.

You will lead site activation, collaborate with Clinical Operations and partners, and drive data-driven forecasts while leveraging industry tools to improve timelines and quality across studies.