Description
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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