Management of clinical study mainly in the EU and the US..Commencement and successful completion of clinical research studies
? Monitor and report on the progress, budgets and timelines
? Prepare, oversee, and review documents that are related to assigned clinical study
? Be involved with vendor selection and work closely with the CRO/CRA to closely manage the trial progress.
? Review the monitoring report and perform CAPA as required
? Arranging and overseeing site visits.
? Assuring compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.
? Ensure the availability of necessary resources for the execution of clinical projects (Budget, Vendors, Contracts etc)
? Review and approve invoices being presented by study vendors and external consultants
? Answerable to questions and issues brought
Requirements: ? Excellent communication skills
? Good problem-solving, organizational, and leadership skills are highly required
? Ability to work with little supervision
? A previous experience in ophthalmology studies will be a bonus.
? Ability to pay keen attention to detail at all times
? Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
? Must be able to work as part of a team or in most cases lead a team
? Ability to organize and motivate other members of the study team
? A Bachelors and/or a Masters degree in any science or health related field
? A minimum of 5 years experience in the field of clinical research of which 2 years must have been in a project lead role
? Proficient with Microsoft Office Word and Excel.
? Experience in writing clinical study procedures and other clinical document is a plus.
המשרה מיועדת לנשים ולגברים כאחד.