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. 

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