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ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Associate to join our diverse and dynamic team. To be an integral part of the study team by providing administrative and project tracking support to the Project Manager(s) and Clinical Trial Manager(s) with emphasis on supporting inspection readiness. Support operational aspects of managed trials, across all trial phases (planning, start-up, execution, data analysis, reporting and closure). Recognize, exemplify and adhere to ICON’s values. Embrace and contribute to ICON’s culture of process improvement with a focus on adding value to our business and meeting client needs. Tracking trial related supplies and data including tracking progress towards planned milestones, as well as related progress analysis, and associated follow-up required. Tracking the trial and country budgets and support invoice reconciliation. Supporting protocol and country feasibility, site selection, and vendor set-up. Performing activities related to trial systems, including specific system set-up, access management, data entry, trial level tracking activities. Responsible for internal and external meeting planning, coordination, outcome documentation, and related follow up. Responsible for Document management.
Job Responsibility:
Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list
Set-up of trial specific training curriculum and follow up on timely training completion
Support activities for quality oversight and inspection readiness
Work with internal partners to assist in management of activities such as country and site feasibility and obtaining country-specific clinical trial insurance
Work with internal partners, and external vendors including Contract Research Organization/Academic Research Organization for outsourced trials/activities
Assist with applicable system support, including tracking of vendor work orders and change orders, tracking and analyzing the trial budget, including actual vs. plan trial budget spend, follow-up on variances, as needed
Provide overview of data management metrics as needed, including status of data entry/missing pages, source data verification progress, and query resolution
Participate in preparation for and conduct of Health Authority inspections and internal audits
Conduct activities to support timely and successful database locks
May contribute to process improvement and/or non-project work
Requirements:
At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others