- Partners with Clinical Operations to develop and deliver Site Feasibility plans.
- Coordinates organizational resources relating to Country & Site feasibility
- Performs tasks for multiple Site Intelligence and Feasibility projects.
- Supports Study Optimization Leadership/Head of Site Feasibility and Selection on special projects
- Leads and/or participates in global initiatives to improve operational efficiencies.
- Works independently with minimal supervision
- Supports, manages processes and coordinates organizational resources relating to Country & Site feasibility.
- Maintains continuity connecting and documenting work performed by the Feasibility Lead in Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Site Selection.
- Leads 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 feasibility.
- Operational responsibility for delivering Site Intelligence and/or Site Feasibility agreed KPIs for assigned projects.
- Acts as primary contact for the study team in the site feasibility process. Participates in the Site Feasibility 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 and site feasibility 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 and Feasibility 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 and Feasibility initiatives with a variety of stakeholders, both internal and external. Initiatives will be diverse and may include technology and process improvement components.
- Leverages knowledge as subject matter expert and through process ownership drives concepts and theories within CD&O
- Additionally runs operational and technical aspects of large global projects and assists with other Company systems activities related to the Site Intelligence and Feasibility.
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
- Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery
- Coordinates organizational resources to support build of data driven study / program assumptions.
- Support governance processes by providing site feasibility information leveraging existing data sources and organizational knowledge/expertise.
- Partners with Alliance Partners, Global Head of SSU, DevOps teams, and RU/BU partners to improve overall study start up metrics and implement simple processes.
- In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:
- BS/Equivalent – 10 years
- MS – 8 years
- PhD/MD – 6 years
- At least 4-6 years of leading complex cross functional teams as well as managing teams
- Leadership, project/resource management (project, staff, finances), administrative, and technical capabilities are required
- 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.
- Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment.
EEO & Employment Eligibility