Partners with Clinical Operations to develop and deliver Site Intelligence plans.
Performs tasks for multiple Site Intelligence projects.
Supports Study Optimization Leadership/Head of Site Intelligence on special projects
Leads and/or participates in global initiatives to improve operational efficiencies.
Supports, manages processes relating to Country and Site Intelligence.
Maintains continuity connecting and documenting work performed by the Feasibility Lead in Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Site Selection.
Supports the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinates global efforts for site intelligence.
Acts as primary contact for the study team in the site intelligence process.
Participates in the site intelligence by leading the preparation of the country plan for the study (number of sites proposed, type of sites, recruitment rates, and key challenges) coordinating site intelligence resources to ensure timely completion of tasks and high quality.
Engages with therapeutic business units to support and deliver the implementation and delivery of specific site intelligence initiatives through good communication, clear implementation plans and explicit performance metrics to agreed timelines and quality,
Creates awareness by working as a cross functional team leader to deliver site intelligence initiatives with a variety of stakeholders, both internal and external. Initiatives will be diverse and may include technology and process improvement components.
Supports and maintains the development of relevant information libraries and communication materials to assist with site intelligence activities.
Additionally runs operational and technical aspects of large global projects and assists with other Company systems activities related to the site intelligence.
Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
BS/Equivalent and 8 years of experience
MS and 6 years of experience
PhD/MD and 4 years of experience
Feasibility experience mandatory
Experience in a clinical research organization and related therapeutic specialties with familiarity in principles, concepts, practices and standards.
History of success in a customer service role with demonstration of meeting customer expectations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications)
Strong presentation skills, interpersonal skills, as well as a team oriented approach.
Excellent verbal, written, communication and time management skills
Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work.
Demonstrated knowledge of clinical research processes and regulatory requirements.
Demonstrated success/results in prior roles including matrix organization