Senior Clinical Associate

POL
- Sr CTA- HB

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.

• 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 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.

• Advanced degree in a relevant field such as life sciences, clinical research, or a related discipline.
• At least two years as CTA.
• Proven ability to manage multiple projects effectively, with strong organizational and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and…