Manager, Site Start up

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Job Description

Objective / Purpose:

• As an experienced professional, you will work independently under general direction, using your expertise to solve complex problems related to clinical study start up.
• You will analyze diverse data and apply established methods, processes, and policies to determine appropriate solutions.
• As part of the role, you will also support and manage the day-to-day work of colleagues, including those working within an FSP model, through direction, guidance, knowledge sharing, and training.

Accountabilities:

• 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.

Experience & Competencies:

• 4 or more years of experience in Clinical Operations, Project Management, site start up and/or trial optimization, with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
• At least 2 years of direct responsibility in site activation and managing site start up processes for clinical research studies at a sponsor or CRO.
• Expertise in principles driving country/site start up and study start up strategies.
• Understanding and application of Good Clinical Practice (GCP) and relevant clinical trial requirements.
• Proficiency with software models and database structures.
• Ability to interpret and explain data and facilitate data-driven decision-making.
• Ability to manage complex activities with a high level of attention to detail.
• Ability to work independently and collaborate effectively with internal and external stakeholders.
• Ability to identify and resolve complex site start up issues and escalate risks where appropriate.
• Exposure to formal or informal people management, including providing direction, guidance and support to team members.
• Demonstrated ownership and accountability, with a proactive approach to driving activities through completion.
• Motivation to make an impact by improving ways of working and contributing to better study start up performance.
• European Site Start Up experience preferred.

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time