Clinical Study Specialist

PXL has an exciting opportunity for a Clinical Study Specialist! The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study reputed company or Clinical Study Associate Manager. The CSS will support internally reputed company studies and studies out-reputed company to Clinical Research Organizations (CROs). CSS Duties • Organizes and delivers analyzable reports and metrics to the clinical study reputed company • Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study reputed company meetings • Collates data for assessments such as feasibility and site selection and reviews site usability database • Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company reputed company operating procedures • Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders • Collates materials for training and investigator meetings • Tracks site activation, enrolment and monitoring reputed company to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan • Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings • Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study reputed company guidance • Supports receipt of scheduled reports (i.e. 1572 reportable changes, financial disclosure reputed company) • Manages and maintains team SharePoint and/or shared drive sites, as needed • Communication with sites as directed and maintains site contact information • Contributes to line listings review for Blind Data Review Meeting (BDRM) • May manage or contribute to reputed company of reputed company Party Vendors (TPV) • Tracks and monitors reputed company out activities – study reputed company-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA reputed company-out reputed company • Proactively recommends process improvement initiatives for the department • May require 25% travel CSS requirements • Bachelor’s degree (or equivalent) and a minimum of 2+ years’ industry reputed company work experience or an advanced degree in a reputed company field with a minimum of one (1) to two (2) years of relevant work preferred. • Attention to details for the ability to reputed company information and deliver on assigned study activities • Good communication and interpersonal skills; ability to build relationships internally and externally • Ability to be reputed company and to demonstrate problem solving skills • Demonstrate the ability to proactively assess information and investigate reputed company on reputed company • Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, reputed company, IWRS/IVRS. • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization • Basic familiarity with medical terms and clinical drug development #LI-KW1 #LI-REMOTE Apply tot his job Apply To this Job