Global Clinical Trial Assistant
An exciting new role has arisen for a Global Clinical Trial Associate in the Netherlands. This is an amazing opportunity for a bright individual to develop their clinical career at a renowned Clinical Research Organisation
- The person will be responsible for supporting the physicians (globally)and their patients by checking and approving the orders J&J received via the MAcWeb system as well as support the internal team by checking and approving documentation.
- Responsible for communicating effectively and answering promptly to colleagues and physicians for queries regarding the local affiliates, local depots, vendors, ect.
- Be accountable for keeping track of the drug accountability in local depots, and escalating issues promptly to management when necessary
- Assisting the GTL/TM with the creation and updating of the program documents and helping the GTL/TM with quality checks; run reports, help to solve mismatches, ect.
- Attend study management team meetings for each project and maintains documentation from meetings
- Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary
- Maintains internal project specific study sites to ensure availability of all central project documents.
- Liaises with external service providers (ESP) and contract research organisations (CRO) as needed.
- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
- With focus on quality, supports GTL, TM, GPL and Quality Assurance (QA) team with audit findings report and CAPA management
- Keeps the trial in compliance with local regulatory requirements by organising and ensuring IEC/HA approvals, when applicable.
Skills and Requirements:
- Bachelor's degree or equivalent Degree in a health or science related field
- Experience in clinical research experience in the pharmaceutical industry or CRO
- Literacy and proficiency in IT skills with appropriate software and company systems
- Proficiency in English
- Proven ability to plan and track deliverables and timelines
- Individual must work well in a dynamic environment and be able to prioritise and respond to changing needs of the business
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