Site Start-Up Lead - Clinical Operations

Takeda; Województwo mazowieckie; On-site; PLN 90,000 - 130,000; Full time

Job summary

Takeda in Warsaw, Poland invites an experienced clinical operations professional to lead site start up activities within a dynamic global environment. You will drive start up planning, governance and delivery for Takeda and CRO-supported sites, ensuring readiness for enrollment and alignment with regulatory requirements.

The role requires strong expertise in country/site start up strategies, GCP knowledge, data modeling and stakeholder collaboration to improve performance across multiple

Qualifications

• 4+ years in Clinical Operations or related fields with rising responsibility.
• At least 2 years in site activation and site start up for clinical studies.
• Expertise in country/site start up and study start up strategies.
• Strong GCP knowledge and trial regulatory requirements.
• Proficiency with data models and forecasting tools.
• Ability to manage complex activities with high attention to detail.
• Ability to work independently and collaborate with stakeholders.
• People management experience is a plus.
• European Site Start Up experience preferred.

Responsibilities

• Establish, develop and deliver the Site Start Up Plan.
• Lead the Site Start Up team to implement the plan and drive delivery of Takeda and CRO-supported sites to Ready to Enroll status.
• Partner with Clinical Operations teams and TAU partners to improve site start up metrics, processes and overall study initiation performance.
• Provide guidance and oversight to the Site Start Up team across Clinical Programs, including protocol study start up, country and site selection, planning and modeling.
• Oversee the collection and analysis of clinical trial data to drive accurate, data-driven study start up forecasts, benchmarking, and scenario planning.
• Leverage industry tools and data sources to evaluate start up timelines, data quality and cycle times, supporting project teams with site initiation forecasting and decision-making.
• Ensure consistent standards are applied across project portfolios and contribute to continuous improvement of Site Start Up processes, methodologies and technologies.
• Develop site start up strategies aligned with therapeutic area needs.
• Agree site-level deliverables with the Site Start Up team, monitor performance and proactively address potential delays or non-performance.
• Resolve escalated site start up issues in partnership with the Study Manager.
• As part of the role, provide ongoing management, guidance and operational support to FSP colleagues, helping them navigate site start up activities, resolve operational issues and deliver against agreed expectations.
• Ensure site start up activities comply with Good Clinical Practice (GCP) and applicable regulatory requirements.

Skills

Clinical Operations

Project Management

Site Start Up

Data-driven decision making

Independent work

Stakeholder collaboration

GCP understanding

Tools

Software models

Database structures

Job description

Takeda in Warsaw, Poland invites an experienced clinical operations professional to lead site start up activities within a dynamic global environment. You will drive start up planning, governance and delivery for Takeda and CRO-supported sites, ensuring readiness for enrollment and alignment with regulatory requirements.

The role requires strong expertise in country/site start up strategies, GCP knowledge, data modeling and stakeholder collaboration to improve performance across multiple