Site Start Up Lead (FSP)

OBJECTIVES

• Drive rapid, accurate, and data-driven study start up forecasts, benchmarking assumptions, scenarios and accurate planning. 

• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Start Up Services. 

ACCOUNTABILITIES

• Partner with Clinical Operations teams, and TAU partners to improve overall study start up metrics and implement processes. 

• Provide guidance, oversight, and mentoring to the FSP Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling. 

• Create country-specific ICFs based on the Master ICF provided. 

• Ensure standards are applied to the site  start up process across project portfolios and support continuous improvement activities while developing the process.. 

• Guide the collection and analysis of all data to influence study start up timelines. 

• Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with study initiation timeline forecasting. 

• Agree to deliverables on a site-level basis with the internal team and monitor adherence to these. Promptly recognize and improve potential delays, and escalate non-performance. 

• Lead the internal FSP site start up team, using the appropriate team members to help implement the Start Up Project Plan. 

• Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll" to the Start Up Project Plan. Resolve escalated issues identified by the site start up -team in partnership with the Study Manager  

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• BS degree or international equivalent in a life science. 

• 4 or more years of experience in Clinical Operations, Project Management, study start up, and 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 the study start up processes of clinical research studies at a sponsor or CRO. 

• Experience and knowledge with country level ICF creation and requirements. 

• Proficiency with software models and database structures. 

• Glo