Global Studies Associate

ICON plc•Burlington, PE

About The Position

Global Studies Associate 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.

Requirements

Education in in medical or biological sciences or discipline associated with clinical research preferred.
Proven organizational and analytical skills.
Previous administrative training/experience.
Computer proficiency in day-to-day tasks.
Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.
Excellent verbal and written communication in English.
Demonstrate ability to work independently, as well as in a team environment.
Willingness and ability to train others on study administration procedures.
Experience managing eTMF and CTMS systems is required (Veeva Vault experience preferred).

Nice To Haves

Global study support experience preferred but not required.

Responsibilities

Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.
Initiate and lead the set-up of the electronic Trial Master File (eTMF).
Maintain and close the eTMF to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
Collaborate with Site Management & Monitoring, extended study team and external vendors in collection of regulatory and other essential documents.
Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection.
Contribute to electronic applications/submissions by creating and managing clinical- regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory.
Proactively plan and collate the administrative appendices for the CSR.
Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.
Set-up, populate and accurately maintain information in tracking and communication tools and support team members in the usage of these tools.
Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.
Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/ payments in relevant systems.
Contribute to application, coordination, supply and tracking of study materials and Contribute to collection of study supplies, if required, at the study close-out.
Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.
Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings.
Liaise with internal and external participants and/or vendors.

Benefits

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize 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.

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