Unclassified - Armonk, NY
posted 3 months ago
The Clinical Study Specialist (CSS) provides essential technical and administrative support to the clinical study team(s) responsible for executing clinical trials. This role is pivotal in ensuring that studies are conducted efficiently and in compliance with regulatory standards. The CSS may be assigned to support the execution of one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will be involved in both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). This position is hybrid, requiring the individual to work onsite three days a week, with full remote work not being an option. A typical day for a Clinical Study Specialist may include organizing and delivering analyzable reports and metrics to the clinical study lead, scheduling and coordinating meetings, and preparing agendas, presentation materials, and minutes for clinical study team meetings. The CSS will collate data for assessments such as feasibility and site selection, review site usability databases, and contribute to the review of study documents, including informed consent forms and case report forms, ensuring compliance with company standard operating procedures. Additionally, the CSS compiles study manuals, maintains versioning of study reference materials, tracks site activation, enrollment, and monitoring visits, and escalates any issues or delays. The role also involves monitoring and updating investigator/site status for the trial, supporting clinical trial registry postings, and performing scheduled reconciliations of the Trial Master File (TMF) under the guidance of the clinical study lead. The CSS will manage team SharePoint and/or shared drive sites, communicate with sites as directed, and contribute to line listings review for Blind Data Review Meetings (BDRM). Furthermore, the CSS may manage or contribute to oversight of Third-Party Vendors (TPV) and track close-out activities, ensuring all study close-out documents are completed accurately. The ideal candidate for this role will have a strong attention to detail, excellent communication and interpersonal skills, and the ability to proactively assess information and investigate its impact on clinical trials. This position requires a Bachelor's degree with at least two years of relevant pharmaceutical industry experience, or in lieu of a degree, five years of relevant experience focused on clinical operations or trial management.